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FDA 510(k)

GGT PROCEDURE OR GAMMA GLUTAMYL TRANSFERASE PROCED

K-Number: K844720 · 1984-12-12

ApplicantData Medical Associates, Inc.
Decision Date1984-12-12
Product CodeJQB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GGT PROCEDURE OR GAMMA GLUTAMYL TRANSFERASE PROCED is the device name listed in this FDA 510(k) record. The listed applicant is Data Medical Associates, Inc.. It received FDA 510(k) clearance on 1984-12-12 under 510(k) number K844720. 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 GGT PROCEDURE OR GAMMA GLUTAMYL TRANSFERASE PROCED?

GGT PROCEDURE OR GAMMA GLUTAMYL TRANSFERASE PROCED is a medical device that received FDA 510(k) clearance on 1984-12-12. The listed applicant is Data Medical Associates, Inc.. The 510(k) number is K844720.

When did GGT PROCEDURE OR GAMMA GLUTAMYL TRANSFERASE PROCED receive FDA 510(k) clearance?

GGT PROCEDURE OR GAMMA GLUTAMYL TRANSFERASE PROCED received FDA 510(k) clearance on 1984-12-12, under 510(k) number K844720.

Who is the listed applicant for GGT PROCEDURE OR GAMMA GLUTAMYL TRANSFERASE PROCED?

The FDA 510(k) record lists Data Medical Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GGT PROCEDURE OR GAMMA GLUTAMYL TRANSFERASE PROCED?

The FDA product code for GGT PROCEDURE OR GAMMA GLUTAMYL TRANSFERASE PROCED is JQB.

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Other records listing Data Medical Associates, 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.

K993098HDL-C/LDL-C CALIBRATOR, MODEL 1913-003K971113DMA TRIGLYCERIDES PROCEDURESK961919DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDUREK955302SERUM BICARBONATE/CARBON DIOXIDEK955796IRON CALIBRATOR & CALIBRATION VERIFICATION SETK955300TOTAL BILIRUBIN PROCEDURE

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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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