BILIRUBIN (DIRECT) QVET— 510(k) K942949

Substantially Equivalent

Prisma Systems

FDA 510(k) clearance K942949 for BILIRUBIN (DIRECT) QVET, Substantially Equivalent on 1994-11-22. Applicant: Prisma Systems. Device class: 2.

Clearance details

Applicant: Prisma Systems
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 1994-06-23
Decision date: 1994-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rome, NY, US

Download summary PDF View on FDA.gov ↗

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