GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST— 510(k) K935177

Name: FDA 510(k) clearance K935177
Creator: U.S. Food and Drug Administration
Published: 1993-12-16

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K935177 for GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST, Substantially Equivalent on 1993-12-16. Applicant: Em Diagnostic Systems, Inc.. Device class: 1.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code JQB
Device class: Class 1
Regulation: 21 CFR 862.1360
Advisory panel: Clinical Chemistry
Date received: 1993-10-26
Decision date: 1993-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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K964457 — ROCHE COBAS IBTEGRA REAGENT CASSETTES1997-01-13
K964916 — GAMMA-GLUTAMYL TRANSPEPTIDASE1997-01-10

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K935179 — EMDS ALBUMIN (ALB) TEST1993-12-17
K935136 — CHOLESTEROL (CHOL) TEST ITEM NO. 654101993-12-16

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