VENTANA MMR IHC Panel (K260776): 510(k) cleared for Roche Tissue Diagnostics, Inc.
VENTANA MMR IHC Panel (K260776): 510(k) cleared for Roche Tissue Diagnostics, Inc. (Arizona): 510(k) cleared for Roche Tissue Diagnostics, Inc. Its amount of 227 is above the median of 138 (72nd percentile). Dated 13 days ago, it is in the active follow-up window. Score 54/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 227 · 72th percentile of 414 FDAPulse records · 1.6x the median
Free preview: all 14 published fields of this record are shown below. Locked: 5 related AZ FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260776 |
| Device | VENTANA MMR IHC Panel |
| Applicant | Roche Tissue Diagnostics, Inc. |
| Specialty / panel | Other |
| Product code | PZJ |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-03-10 |
| Decision date | 2026-10-23 |
| Review time (days) | 227 |
| Third-party review | No |
| Applicant location | Tucson, AZ, US |
| amount percentile | 72th of 414 (median 138, 1.6x median) |
| Peer records CSV (6 AZ records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-23
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (AZ first): ProRib Fixation System (K261892) · Reprocessed BRK Transseptal Needle (K262917) · Class II recall Z-0158-2027 · Class II recall Z-0085-2027 · Class II recall Z-3275-2026 · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: VENTANA MMR IHC Panel (K260776): 510(k) cleared for Roche Tissue Diagnostics, Inc. and 6 Arizona peers
- Arizona FDAPulse records like this one: 6
- VENTANA MMR IHC Panel (K260776): 510(k) cleared for Roche Tissue Diagnostics, Inc.'s amount: 72nd percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Arizona peer: $1,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
54 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 227-day review, longer than typical.
- Posted 13 days ago.
What is the FDAPulse record for VENTANA MMR IHC Panel (K260776): 510(k) cleared for Roche Tissue Diagnostics, Inc. in Arizona?
VENTANA MMR IHC Panel (K260776) by Roche Tissue Diagnostics, Inc. was cleared on 2026-10-23 after 227 days of review.
How does VENTANA MMR IHC Panel (K260776): 510(k) cleared for Roche Tissue Diagnostics, Inc. compare to other Arizona FDAPulse records?
Its amount of 227 sits in the upper half (72th percentile) of 414 records; the median is 138. It is fresh: dated 13 days ago, inside the window where early outreach matters most.
VENTANA MMR IHC Panel (K260776) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| VENTANA MMR IHC Panel (K260776) | AZ | 2026-10-23 |
| Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K260230) | CN | 2026-10-22 |
| STA® - Liquid Anti-Xa (K260214) | NJ | 2026-09-24 |
| BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5) (K260215) | CA | 2026-10-20 |
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