AMYLASE QVET— 510(k) K942961

Substantially Equivalent

Prisma Systems

FDA 510(k) clearance K942961 for AMYLASE QVET, Substantially Equivalent on 1994-12-09. Applicant: Prisma Systems. Device class: 2.

Clearance details

Applicant
Prisma Systems
Product code
Code JFJ
Device class
Class 2
Regulation
21 CFR 862.1070
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Rome, NY, US
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