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FDA 510(k)

TARGET COCAINE METABOLITE-R

K-Number: K910122 · 1991-03-19

ApplicantV-Tech, Inc.
Decision Date1991-03-19
Product CodeKLN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TARGET COCAINE METABOLITE-R is the device name listed in this FDA 510(k) record. The listed applicant is V-Tech, Inc.. It received FDA 510(k) clearance on 1991-03-19 under 510(k) number K910122. The device is classified under product code KLN. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TARGET COCAINE METABOLITE-R?

TARGET COCAINE METABOLITE-R is a medical device that received FDA 510(k) clearance on 1991-03-19. The listed applicant is V-Tech, Inc.. The 510(k) number is K910122.

When did TARGET COCAINE METABOLITE-R receive FDA 510(k) clearance?

TARGET COCAINE METABOLITE-R received FDA 510(k) clearance on 1991-03-19, under 510(k) number K910122.

Who is the listed applicant for TARGET COCAINE METABOLITE-R?

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

What is the FDA product code for TARGET COCAINE METABOLITE-R?

The FDA product code for TARGET COCAINE METABOLITE-R is KLN.

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Other records listing V-Tech, Inc. 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.

K914303TARGET(TM)-HOGK910893TARGET(TM) CANNABINOIDS-R TESTK910892TARGET(TM) CANNABINOIDS-V TESTK910739TARGET AMPHETAMINE/METHAMPHETAMINE-R (READER METH)K910738TARGET AMPHETAMINE/METHAMPHETAMINE-V (VISUAL METH)K910123TARGET COCAINE METABOLITE-V

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Related Devices (Code: KLN)

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.

K010868PSYCHEMEDICS RIA COCAINE ASSAYPsychemedics Corp.K913867URINE COCAINE METABOLITE DIRECT RIA KIT (I-125)Immunalysis CorporationK913722ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITERoche Diagnostic Systems, Inc.K912756ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITERoche Diagnostic Systems, Inc.K910123TARGET COCAINE METABOLITE-VV-Tech, Inc.K910044MILENIA COCAINE METABOLITEDiagnostic Products 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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