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FDA 510(k)

KING DIAGNOSTICS GAMMA GT REAGENT

K-Number: K923091 · 1992-09-09

ApplicantKing Diagnostics, Inc.
Decision Date1992-09-09
Product CodeJPZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KING DIAGNOSTICS GAMMA GT REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is King Diagnostics, Inc.. It received FDA 510(k) clearance on 1992-09-09 under 510(k) number K923091. 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 KING DIAGNOSTICS GAMMA GT REAGENT?

KING DIAGNOSTICS GAMMA GT REAGENT is a medical device that received FDA 510(k) clearance on 1992-09-09. The listed applicant is King Diagnostics, Inc.. The 510(k) number is K923091.

When did KING DIAGNOSTICS GAMMA GT REAGENT receive FDA 510(k) clearance?

KING DIAGNOSTICS GAMMA GT REAGENT received FDA 510(k) clearance on 1992-09-09, under 510(k) number K923091.

Who is the listed applicant for KING DIAGNOSTICS GAMMA GT REAGENT?

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

What is the FDA product code for KING DIAGNOSTICS GAMMA GT REAGENT?

The FDA product code for KING DIAGNOSTICS GAMMA GT REAGENT is JPZ.

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Other records listing King Diagnostics, 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.

K933329KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENTK931834KING SODIUM/POTASSIUM STANDARD MODIFIEDK931773HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)K931326KING DIAGNOSTICS CK REAGENTK923129KING DIAGNOSTICS GLUCOSE (HK) REAGENTK922969KING DIAGNOSTICS UREA NITROGEN REAGENT

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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.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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