GAMMA GLUTAMYLTRANSFERASE— 510(k) K873378

Substantially Equivalent

Catachem, Inc.

FDA 510(k) clearance K873378 for GAMMA GLUTAMYLTRANSFERASE, Substantially Equivalent on 1987-09-08. Applicant: Catachem, Inc.. Device class: 1.

Clearance details

Applicant: Catachem, Inc.
Product code: Code JQB
Device class: Class 1
Regulation: 21 CFR 862.1360
Advisory panel: Clinical Chemistry
Date received: 1987-08-24
Decision date: 1987-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Chester, NY, US

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