Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GAMMA GLUTAMYL TRANSFERASE PROCEDURE

K-Number: K863586 · 1986-10-03

ApplicantData Medical Associates, Inc.
Decision Date1986-10-03
Product CodeJPZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GAMMA GLUTAMYL TRANSFERASE 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 1986-10-03 under 510(k) number K863586. 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 GAMMA GLUTAMYL TRANSFERASE PROCEDURE?

GAMMA GLUTAMYL TRANSFERASE PROCEDURE is a medical device that received FDA 510(k) clearance on 1986-10-03. The listed applicant is Data Medical Associates, Inc.. The 510(k) number is K863586.

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

GAMMA GLUTAMYL TRANSFERASE PROCEDURE received FDA 510(k) clearance on 1986-10-03, under 510(k) number K863586.

Who is the listed applicant for GAMMA GLUTAMYL TRANSFERASE 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 GAMMA GLUTAMYL TRANSFERASE PROCEDURE?

The FDA product code for GAMMA GLUTAMYL TRANSFERASE PROCEDURE is JPZ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

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.K961919DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDUREData Medical Associates, Inc.K923509GAMMA-GTRandox Laboratories, Ltd.K923091KING DIAGNOSTICS GAMMA GT REAGENTKing Diagnostics, Inc.K905618GGT REAGENTAmresco, Inc.K903304ROCHE COBAS READY GGT REAGENTRoche Diagnostic Systems, 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.

↑