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FDA 510(k)

EMDS GAMMA-GLUTAMYL TRANSFERASE (GGT) 67680/95

K-Number: K872322 · 1987-07-27

ApplicantEm Diagnostic Systems, Inc.
Decision Date1987-07-27
Product CodeJQB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EMDS GAMMA-GLUTAMYL TRANSFERASE (GGT) 67680/95 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 1987-07-27 under 510(k) number K872322. 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 EMDS GAMMA-GLUTAMYL TRANSFERASE (GGT) 67680/95?

EMDS GAMMA-GLUTAMYL TRANSFERASE (GGT) 67680/95 is a medical device that received FDA 510(k) clearance on 1987-07-27. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K872322.

When did EMDS GAMMA-GLUTAMYL TRANSFERASE (GGT) 67680/95 receive FDA 510(k) clearance?

EMDS GAMMA-GLUTAMYL TRANSFERASE (GGT) 67680/95 received FDA 510(k) clearance on 1987-07-27, under 510(k) number K872322.

Who is the listed applicant for EMDS GAMMA-GLUTAMYL TRANSFERASE (GGT) 67680/95?

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 EMDS GAMMA-GLUTAMYL TRANSFERASE (GGT) 67680/95?

The FDA product code for EMDS GAMMA-GLUTAMYL TRANSFERASE (GGT) 67680/95 is JQB.

Related Clinical Trials

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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)

View all 288 devices →

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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