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FDA 510(k)

QUANTIMETRIX TOTAL CREATINE KINASE CONTROL

K-Number: K874302 · 1988-02-02

ApplicantQuantimetrix Medical Industries
Decision Date1988-02-02
Product CodeJJT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUANTIMETRIX TOTAL CREATINE KINASE CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Quantimetrix Medical Industries. It received FDA 510(k) clearance on 1988-02-02 under 510(k) number K874302. The device is classified under product code JJT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTIMETRIX TOTAL CREATINE KINASE CONTROL?

QUANTIMETRIX TOTAL CREATINE KINASE CONTROL is a medical device that received FDA 510(k) clearance on 1988-02-02. The listed applicant is Quantimetrix Medical Industries. The 510(k) number is K874302.

When did QUANTIMETRIX TOTAL CREATINE KINASE CONTROL receive FDA 510(k) clearance?

QUANTIMETRIX TOTAL CREATINE KINASE CONTROL received FDA 510(k) clearance on 1988-02-02, under 510(k) number K874302.

Who is the listed applicant for QUANTIMETRIX TOTAL CREATINE KINASE CONTROL?

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

What is the FDA product code for QUANTIMETRIX TOTAL CREATINE KINASE CONTROL?

The FDA product code for QUANTIMETRIX TOTAL CREATINE KINASE CONTROL is JJT.

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Other records listing Quantimetrix Medical Industries 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.

K895778QUANTIMETRIX BILIRUBIN CALIBRATORSK883395ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZYK883247LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROLK874890QUANTIMETRIX URINE DIPSTICK CONTROLK873011QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2K873467QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL

View all 8 devices →

Related Devices (Code: JJT)

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.

K090940SPOTCHECK BLOOD SPOT CONTROL, ASSAYEDAstoria-Pacific, Inc.K062751MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKERQuantimetrix Corp.K030768CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVELCliniqa CorporationK030102ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3Bayer Healthcare, LLCK021498LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVELBio-RadK012656LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648Bio-Rad

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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