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FDA 510(k)

GILCHEM Y-GT REAGENT

K-Number: K822149 · 1982-08-12

ApplicantGilford Diagnostics
Decision Date1982-08-12
Product CodeJPZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GILCHEM Y-GT REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Gilford Diagnostics. It received FDA 510(k) clearance on 1982-08-12 under 510(k) number K822149. 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 GILCHEM Y-GT REAGENT?

GILCHEM Y-GT REAGENT is a medical device that received FDA 510(k) clearance on 1982-08-12. The listed applicant is Gilford Diagnostics. The 510(k) number is K822149.

When did GILCHEM Y-GT REAGENT receive FDA 510(k) clearance?

GILCHEM Y-GT REAGENT received FDA 510(k) clearance on 1982-08-12, under 510(k) number K822149.

Who is the listed applicant for GILCHEM Y-GT REAGENT?

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

What is the FDA product code for GILCHEM Y-GT REAGENT?

The FDA product code for GILCHEM Y-GT REAGENT is JPZ.

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Other records listing Gilford Diagnostics 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.

K832094BILIRUBIN CALIBRATORS & CONTROLK831844DIRECT BILIRUBIN REAGENTK831843GILCHEM TOTAL BILIRUBIN REAGENTK823709TRIGLYCERIDE REAGENT (UV)K822739AHBDK822334BILIRUBIN CALIBRATORS

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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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