IRON QVET— 510(k) K943029

Substantially Equivalent

Prisma Systems

FDA 510(k) clearance K943029 for IRON QVET, Substantially Equivalent on 1994-12-02. Applicant: Prisma Systems. Device class: 1.

Clearance details

Applicant: Prisma Systems
Product code: Code JIY
Device class: Class 1
Regulation: 21 CFR 862.1410
Advisory panel: Clinical Chemistry
Date received: 1994-06-27
Decision date: 1994-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rome, NY, US

Download summary PDF View on FDA.gov ↗

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More clearances from Prisma Systems

K950177 — CK QVET1995-03-03
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K942963 — GLUCOSE QVET1994-12-29
K942964 — LACTATE DEHYDROGENASE QVET1994-12-29
K942997 — ALKALINE PHOSPHATASE (ALKP) QVET1994-12-29

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