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FDA 510(k)

ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZY

K-Number: K883395 · 1988-09-19

ApplicantQuantimetrix Medical Industries
Decision Date1988-09-19
Product CodeJJT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZY 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 1988-09-19 under 510(k) number K883395. 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 ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZY?

ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZY is a medical device that received FDA 510(k) clearance on 1988-09-19. The listed applicant is Quantimetrix Medical Industries. The 510(k) number is K883395.

When did ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZY receive FDA 510(k) clearance?

ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZY received FDA 510(k) clearance on 1988-09-19, under 510(k) number K883395.

Who is the listed applicant for ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZY?

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 ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZY?

The FDA product code for ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZY 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 CALIBRATORSK883247LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROLK874302QUANTIMETRIX TOTAL CREATINE KINASE CONTROLK874890QUANTIMETRIX URINE DIPSTICK CONTROLK873011QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2K873467QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL

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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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