PARAMAX ALANINE AMINOTRANSFERASE (GPT) REAGENT— 510(k) K951332

Substantially Equivalent

Dade Intl., Inc.

FDA 510(k) clearance K951332 for PARAMAX ALANINE AMINOTRANSFERASE (GPT) REAGENT, Substantially Equivalent on 1995-06-19. Applicant: Dade Intl., Inc.. Device class: 1.

Clearance details

Applicant
Dade Intl., Inc.
Product code
Code CKA
Device class
Class 1
Regulation
21 CFR 862.1030
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Deerfield, IL, US
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