FDA 510(k)

MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT)

K-Number: K874903 · 1988-02-11

Decision Date1988-02-11

Product CodeJPZ

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT) is the device name listed in this FDA 510(k) record. The listed applicant is Simmler, Inc.. It received FDA 510(k) clearance on 1988-02-11 under 510(k) number K874903. 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 MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT)?

MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT) is a medical device that received FDA 510(k) clearance on 1988-02-11. The listed applicant is Simmler, Inc.. The 510(k) number is K874903.

When did MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT) receive FDA 510(k) clearance?

MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT) received FDA 510(k) clearance on 1988-02-11, under 510(k) number K874903.

Who is the listed applicant for MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT)?

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

What is the FDA product code for MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT)?

The FDA product code for MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT) is JPZ.

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Other records listing Simmler, Inc. as applicant

K895745SICKLE CELL SOLUBILITY TEST KIT K874595MULTICHEM (R) MAGNESIUM REAGENT K874820MULTICHEM HDL PRECIPITATING REAGENT #S0914 K874812MULTICHEM CHLORIDE REAGENT S0933 K874311MULTICHEM (R) TOTAL BILIRUBIN K874049MULTICHEM ALBUMIN REAGENT S0902

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Related Devices (Code: JPZ)

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.