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FDA 510(k)

DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE

K-Number: K961919 · 1996-07-01

ApplicantData Medical Associates, Inc.
Decision Date1996-07-01
Product CodeJPZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE 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 1996-07-01 under 510(k) number K961919. The device is classified under product code JPZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE?

DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE is a medical device that received FDA 510(k) clearance on 1996-07-01. The listed applicant is Data Medical Associates, Inc.. The 510(k) number is K961919.

When did DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE receive FDA 510(k) clearance?

DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE received FDA 510(k) clearance on 1996-07-01, under 510(k) number K961919.

Who is the listed applicant for DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE?

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 DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE?

The FDA product code for DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE is JPZ.

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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 PROCEDURESK955796IRON CALIBRATOR & CALIBRATION VERIFICATION SETK955302SERUM BICARBONATE/CARBON DIOXIDEK955300TOTAL BILIRUBIN PROCEDUREK952437DMA GLUCOSE HEXOKINASE U.V. PROCEDURE

View all 111 devices →

Related Devices (Code: JPZ)

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.

K020486CARESIDE GGTCareside, Inc.K923509GAMMA-GTRandox Laboratories, Ltd.K923091KING DIAGNOSTICS GAMMA GT REAGENTKing Diagnostics, Inc.K905618GGT REAGENTAmresco, Inc.K903304ROCHE COBAS READY GGT REAGENTRoche Diagnostic Systems, Inc.K901090ELITECH GAMMA GT TEST KITElite Technology, 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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