ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD)— 510(k) K883387

Name: FDA 510(k) clearance K883387
Creator: U.S. Food and Drug Administration
Published: 1988-10-13

Substantially Equivalent

Tech-Co, Inc.

FDA 510(k) clearance K883387 for ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD), Substantially Equivalent on 1988-10-13. Applicant: Tech-Co, Inc.. Device class: 1.

Clearance details

Applicant: Tech-Co, Inc.
Product code: Code CKD
Device class: Class 1
Regulation: 21 CFR 862.1030
Advisory panel: Clinical Chemistry
Date received: 1988-08-10
Decision date: 1988-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oak Park, MI, US

Download summary PDF View on FDA.gov ↗

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