SERUM GLUTAMIC-PYRUVIC TRANSAMINASE— 510(k) K780507

Name: FDA 510(k) clearance K780507
Creator: U.S. Food and Drug Administration
Published: 1978-05-03

Substantially Equivalent

Gamma Enterprises, Inc.

FDA 510(k) clearance K780507 for SERUM GLUTAMIC-PYRUVIC TRANSAMINASE, Substantially Equivalent on 1978-05-03. Applicant: Gamma Enterprises, Inc.. Device class: 1.

Clearance details

Applicant: Gamma Enterprises, Inc.
Product code: Code CKC
Device class: Class 1
Regulation: 21 CFR 862.1030
Advisory panel: Clinical Chemistry
Date received: 1978-03-30
Decision date: 1978-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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K790578 — GAMMA SMAC REAGENTS1979-05-15
K780504 — CREATINE PHOSPHOKINASE (CPK)1978-05-03
K780505 — SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE1978-05-03
K780506 — CARBON DIOXIDE REAGENTS1978-05-03
K771832 — CHLORIDE1977-11-22

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