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FDA 510(k)

ELITECH GAMMA GT TEST KIT

K-Number: K901090 · 1990-03-29

ApplicantElite Technology, Inc.
Decision Date1990-03-29
Product CodeJPZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELITECH GAMMA GT TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Elite Technology, Inc.. It received FDA 510(k) clearance on 1990-03-29 under 510(k) number K901090. 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 ELITECH GAMMA GT TEST KIT?

ELITECH GAMMA GT TEST KIT is a medical device that received FDA 510(k) clearance on 1990-03-29. The listed applicant is Elite Technology, Inc.. The 510(k) number is K901090.

When did ELITECH GAMMA GT TEST KIT receive FDA 510(k) clearance?

ELITECH GAMMA GT TEST KIT received FDA 510(k) clearance on 1990-03-29, under 510(k) number K901090.

Who is the listed applicant for ELITECH GAMMA GT TEST KIT?

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

What is the FDA product code for ELITECH GAMMA GT TEST KIT?

The FDA product code for ELITECH GAMMA GT TEST KIT 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.

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Other records listing Elite Technology, 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.

K900733PROTEIN TEST FOR URINE AND CSFK901001URIC ACID TEST KITK895951CHOLESTEROL TEST KITK895952TRIGLYCERIDES TEST KIT

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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