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FDA 510(k)

QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2

K-Number: K873011 · 1987-10-29

ApplicantQuantimetrix Medical Industries
Decision Date1987-10-29
Product CodeLAS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2 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 1987-10-29 under 510(k) number K873011. The device is classified under product code LAS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2?

QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2 is a medical device that received FDA 510(k) clearance on 1987-10-29. The listed applicant is Quantimetrix Medical Industries. The 510(k) number is K873011.

When did QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2 receive FDA 510(k) clearance?

QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2 received FDA 510(k) clearance on 1987-10-29, under 510(k) number K873011.

Who is the listed applicant for QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2?

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 SERUM ALCOHOL CONTROL LEVEL 1 AND 2?

The FDA product code for QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2 is LAS.

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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 CONTROLK874302QUANTIMETRIX TOTAL CREATINE KINASE CONTROLK874890QUANTIMETRIX URINE DIPSTICK CONTROLK873467QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL

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Related Devices (Code: LAS)

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.

K080459CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLSChromsystems Instruments & Chemicals GmbHK072257MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVELMore DiagnosticsK062942QUANTIMETRIX NICOSURE COTININE URINE CONTROLQuantimetrix Corp.K051074MAS IMMUNOSUPPRESSANT CONTROLSMicrogenics Corp.K040411DRI OXYCODONE ASSAYMicrogenics Corp.K032842MICROGENICS CYCLOSPORINE CONTROL KITMicrogenics Corp.

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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