ALANINE TRANSAMINASE (ALT) TEST KIT— 510(k) K870879

Substantially Equivalent

Genetic Systems Corp.

FDA 510(k) clearance K870879 for ALANINE TRANSAMINASE (ALT) TEST KIT, Substantially Equivalent on 1987-03-19. Applicant: Genetic Systems Corp.. Device class: 1.

Clearance details

Applicant
Genetic Systems Corp.
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
Seattle, WA, US
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