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FDA 510(k)

GAMMA GLUTAMYL TRANSPEPTIDASE (KINECTIC)REAGENTSET

K-Number: K855186 · 1986-01-14

ApplicantTechnostics Intl.
Decision Date1986-01-14
Product CodeJPZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GAMMA GLUTAMYL TRANSPEPTIDASE (KINECTIC)REAGENTSET is the device name listed in this FDA 510(k) record. The listed applicant is Technostics Intl.. It received FDA 510(k) clearance on 1986-01-14 under 510(k) number K855186. 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 TRANSPEPTIDASE (KINECTIC)REAGENTSET?

GAMMA GLUTAMYL TRANSPEPTIDASE (KINECTIC)REAGENTSET is a medical device that received FDA 510(k) clearance on 1986-01-14. The listed applicant is Technostics Intl.. The 510(k) number is K855186.

When did GAMMA GLUTAMYL TRANSPEPTIDASE (KINECTIC)REAGENTSET receive FDA 510(k) clearance?

GAMMA GLUTAMYL TRANSPEPTIDASE (KINECTIC)REAGENTSET received FDA 510(k) clearance on 1986-01-14, under 510(k) number K855186.

Who is the listed applicant for GAMMA GLUTAMYL TRANSPEPTIDASE (KINECTIC)REAGENTSET?

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

What is the FDA product code for GAMMA GLUTAMYL TRANSPEPTIDASE (KINECTIC)REAGENTSET?

The FDA product code for GAMMA GLUTAMYL TRANSPEPTIDASE (KINECTIC)REAGENTSET is JPZ.

Related Clinical Trials

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Other records listing Technostics Intl. 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.

K855188CPK (UV) REAGENT KITK860111URIC ACID REAGENT SETK855190MAGNESIUM REAGENT SETK860110GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SETK860109ENZYMATIC UREA NITROGEN REAGENT SETK860112TOTAL LIPIDS REAGENT SET

View all 21 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.

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