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FDA 510(k)

QUANTIMETRIX NICOSURE COTININE URINE CONTROL

K-Number: K062942 · 2006-10-30

ApplicantQuantimetrix Corp.
Decision Date2006-10-30
Product CodeLAS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QUANTIMETRIX NICOSURE COTININE URINE CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Quantimetrix Corp.. It received FDA 510(k) clearance on 2006-10-30 under 510(k) number K062942. 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 NICOSURE COTININE URINE CONTROL?

QUANTIMETRIX NICOSURE COTININE URINE CONTROL is a medical device that received FDA 510(k) clearance on 2006-10-30. The listed applicant is Quantimetrix Corp.. The 510(k) number is K062942.

When did QUANTIMETRIX NICOSURE COTININE URINE CONTROL receive FDA 510(k) clearance?

QUANTIMETRIX NICOSURE COTININE URINE CONTROL received FDA 510(k) clearance on 2006-10-30, under 510(k) number K062942.

Who is the listed applicant for QUANTIMETRIX NICOSURE COTININE URINE CONTROL?

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

What is the FDA product code for QUANTIMETRIX NICOSURE COTININE URINE CONTROL?

The FDA product code for QUANTIMETRIX NICOSURE COTININE URINE CONTROL is LAS.

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Other records listing Quantimetrix Corp. 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.

K113177COMPLETE D 25-OH VITAMIN D CONTROLK103744DROPPER A1C DIABETES CONTROLK062751MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKERK060417MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROLK032791GLYCOHEMOSURE HBA1C CONTROLK030826PRECISET DAT AMPHETAMINE

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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 DiagnosticsK051074MAS IMMUNOSUPPRESSANT CONTROLSMicrogenics Corp.K040411DRI OXYCODONE ASSAYMicrogenics Corp.K032842MICROGENICS CYCLOSPORINE CONTROL KITMicrogenics Corp.K030616CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5Microgenics 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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