Primus Variant System PVS99
FDA 510(k)Class II (US FDA 510(k))
by Primus Corp.
Identifiers
- 510(k) Number
- K955283 FDA 510(k)
- FDA Product Code
- GKA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.7415 FDA 510(k)
- Regulation Number
- 864.7415 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Primus Variant System PVS99 is an abnormal hemoglobin quantitation device. It is designed to measure and quantify hemoglobin variants within clinical samples.
This device is classified as a Class II medical device under regulation number 864.7415. It received FDA 510(k) clearance on March 1, 1996, under the product code GKA.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K955283 FDA 510(k) - PRIMUS VARIANT SYSTEM PVS99 | Primus Corp., PRIMUS VARIANT SYSTEM PVS99 510(k) K955283 - FDA.report, Primus Corp. — FDA 510 (k) clearances & recalls · 510k Monitor
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K955283 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Primus Corp.
Sources (1)
- FDA 510(k) K955283 24 fields · synced Sep 24, 2026