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FDA 510(k)

REAGENT, Y-GT MAX-PACK

K-Number: K760366 · 1976-11-01

ApplicantCalbiochem
Decision Date1976-11-01
Product CodeJPZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REAGENT, Y-GT MAX-PACK is the device name listed in this FDA 510(k) record. The listed applicant is Calbiochem. It received FDA 510(k) clearance on 1976-11-01 under 510(k) number K760366. 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 REAGENT, Y-GT MAX-PACK?

REAGENT, Y-GT MAX-PACK is a medical device that received FDA 510(k) clearance on 1976-11-01. The listed applicant is Calbiochem. The 510(k) number is K760366.

When did REAGENT, Y-GT MAX-PACK receive FDA 510(k) clearance?

REAGENT, Y-GT MAX-PACK received FDA 510(k) clearance on 1976-11-01, under 510(k) number K760366.

Who is the listed applicant for REAGENT, Y-GT MAX-PACK?

The FDA 510(k) record lists Calbiochem as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REAGENT, Y-GT MAX-PACK?

The FDA product code for REAGENT, Y-GT MAX-PACK 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 Calbiochem 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.

K771993AFT SYSTEMK760786ENZYMATIC LIPASE MAX-PACK REAGENT

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.

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