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FDA 510(k)

GAMMA GLUTAMYL TRANSFERASE TEST, ITEM: 65414/R1

K-Number: K893765 · 1989-07-20

ApplicantEm Diagnostic Systems, Inc.
Decision Date1989-07-20
Product CodeJQB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GAMMA GLUTAMYL TRANSFERASE TEST, ITEM: 65414/R1 is the device name listed in this FDA 510(k) record. The listed applicant is Em Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1989-07-20 under 510(k) number K893765. The device is classified under product code JQB. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMMA GLUTAMYL TRANSFERASE TEST, ITEM: 65414/R1?

GAMMA GLUTAMYL TRANSFERASE TEST, ITEM: 65414/R1 is a medical device that received FDA 510(k) clearance on 1989-07-20. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K893765.

When did GAMMA GLUTAMYL TRANSFERASE TEST, ITEM: 65414/R1 receive FDA 510(k) clearance?

GAMMA GLUTAMYL TRANSFERASE TEST, ITEM: 65414/R1 received FDA 510(k) clearance on 1989-07-20, under 510(k) number K893765.

Who is the listed applicant for GAMMA GLUTAMYL TRANSFERASE TEST, ITEM: 65414/R1?

The FDA 510(k) record lists Em Diagnostic Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GAMMA GLUTAMYL TRANSFERASE TEST, ITEM: 65414/R1?

The FDA product code for GAMMA GLUTAMYL TRANSFERASE TEST, ITEM: 65414/R1 is JQB.

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Other records listing Em Diagnostic Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K935181ASPARTATE AMINOTRANSFERASE (AST) TESTK935180ALANINE AMINOTRANSFERASE (ALT) TESTK935178EMDS PHOSPHOROUS (PHOS) TESTK935179EMDS ALBUMIN (ALB) TESTK935175LACTATE DEHYDROGENASE (LD)K935174TOTAL PROTEIN TEST (TPRO)

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Related Devices (Code: JQB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K974000Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30Diagnostic Chemicals , Ltd.K973157LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SETPointe Scientific, Inc.,K971466SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT)Carolina Liquid Chemistries Corp.K964457ROCHE COBAS IBTEGRA REAGENT CASSETTESRoche Diagnostic Systems, Inc.K964916GAMMA-GLUTAMYL TRANSPEPTIDASEDerma Media Lab., Inc.K955770GAMMA GLUTAMYL TRANSFERASE TEST SYSTEMAbaxis, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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