PRIMUS VARIANT SYSTEM PVS99— 510(k) K955283

Substantially Equivalent

Primus Corp.

FDA 510(k) clearance K955283 for PRIMUS VARIANT SYSTEM PVS99, Substantially Equivalent on 1996-03-01. Applicant: Primus Corp.. Device class: 2.

Clearance details

Applicant: Primus Corp.
Product code: Code GKA
Device class: Class 2
Regulation: 21 CFR 864.7415
Advisory panel: Hematology
Date received: 1995-11-16
Decision date: 1996-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kansas City, MO, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K955283

K-number listed on FDA's recall record

Z-0321-2021 — Ultra2 Resolution Variants System for Abnormal Hemoglobin QuantitationClass II·Terminated·Primus Corporation·20201009

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K955283.

Data sourced from openFDA. This site is unofficial and independent of the FDA.