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Elecsys EBV VCA IgG (K260232): 510(k) cleared for Roche Diagnostics vs Elecsys EBV IgM (K260233): 510(k) cleared for Roche Diagnostics: FDAPulse comparison
Elecsys EBV VCA IgG (K260232): 510(k) cleared for Roche Diagnostics's review days of 249 is 1.0x Elecsys EBV IgM (K260233): 510(k) cleared for Roche Diagnostics's 249 (79th percentile). Elecsys EBV VCA IgG (K260232): 510(k) cleared for Roche Diagnostics is dated 2026-10-02; Elecsys EBV IgM (K260233): 510(k) cleared for Roche Diagnostics 2026-10-02.
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Both records plus every comparable record, with all columns and source links · Card, Apple Pay, Google Pay or Link via Stripe
How does Elecsys EBV VCA IgG (K260232): 510(k) cleared for Roche Diagnostics compare to Elecsys EBV IgM (K260233): 510(k) cleared for Roche Diagnostics?
| Field | Elecsys EBV VCA IgG (K260232): 510(k) cleared for Roche Diagnostics | Elecsys EBV IgM (K260233): 510(k) cleared for Roche Diagnostics |
|---|---|---|
| Record | 510(k) clearance | 510(k) clearance |
| 510(k) number | K260232 | K260233 |
| Device | Elecsys EBV VCA IgG | Elecsys EBV IgM |
| Applicant | Roche Diagnostics | Roche Diagnostics |
| Specialty / panel | Microbiology | Microbiology |
| Product code | LSE | LJN |
| Device class | 1 | 1 |
| Clearance type | Traditional | Traditional |
| Decision | Substantially Equivalent | Substantially Equivalent |
| Received | 2026-01-26 | 2026-01-26 |
| Decision date | 2026-10-02 | 2026-10-02 |
| Review time (days) | 249 | 249 |
| Third-party review | No | No |
| Applicant location | Indianapolis, IN, US | Indianapolis, IN, US |
| amount percentile | 79th | 79th |
| Predicate Speed & CAPA Advisory Opportunity Score | 61/100 | 61/100 |
| Peer rank and all 500 records (CSV) | 🔒 Click to unlock → | |
| Official source URLs for every peer record | 🔒 Click to unlock → | |
Official records: Elecsys EBV VCA IgG (K260232): 510(k) cleared for Roche Diagnostics · Elecsys EBV IgM (K260233): 510(k) cleared for Roche Diagnostics
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Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.
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