Hepquant, LLC: PMA approval for HepQuant SHUNT® Liver Diagnostic Test
Hepquant, LLC (Aurora, Colorado): PMA approval for HepQuant SHUNT® Liver Diagnostic Test. Dated 139 days ago, it serves as a historical benchmark. Score 55/100. As of 2026-11-04, from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
Free preview: all 8 published fields of this record are shown below. Locked: 3 related CO FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Hepquant, LLC |
| Product | HepQuant SHUNT® Liver Diagnostic Test |
| Generic / ingredient | Test for Esophageal Varices |
| Approval | PMA original approval (new class III device) |
| Application | P220016 |
| Decided | 2026-06-18 |
| Panel / class | Clinical Chemistry |
| Sponsor location | Aurora, CO |
| Peer records CSV (4 CO records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Sponsor · Product · Approval · Decided · official source URL
- Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
- Record date: 2026-06-18
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 06:06:18 GMT
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Peer benchmark and outreach value: Hepquant, LLC and 4 Colorado peers
- Colorado FdaApprovalPulse records like this one: 4
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Colorado peer: $800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
55 / 100 Score
- A new product launch.
What is the FdaApprovalPulse record for Hepquant, LLC in Aurora, Colorado?
The FDA approved HepQuant SHUNT® Liver Diagnostic Test (P220016) for Hepquant, LLC on 2026-06-18: PMA original approval (new class iii device).
How does Hepquant, LLC compare to other Colorado FdaApprovalPulse records?
It is 139 days old; check the official source for later updates before acting.
Hepquant, LLC vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Hepquant, LLC | Aurora, CO | 2026-06-18 |
| Vivasure Medical , Ltd. | Galway | 2026-10-16 |
| Edwards Lifesciences, LLC | Irvine, CA | 2026-10-01 |
| Rejoni, Inc. | Bedford, MA | 2026-09-28 |
Related records
FdaApprovalPulse: PMA original approval (new class III device) FdaApprovalPulse: records in Colorado
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