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FDA 510(k)

ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC)

K-Number: K040327 · 2004-04-19

ApplicantAccu-Stat Diagnostics, Inc.
Decision Date2004-04-19
Product CodeMVO
DecisionSubstantially Equivalent

Device Summary

ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC) is the device name listed in this FDA 510(k) record. The listed applicant is Accu-Stat Diagnostics, Inc.. It received FDA 510(k) clearance on 2004-04-19 under 510(k) number K040327. The device is classified under product code MVO. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC)?

ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC) is a medical device that received FDA 510(k) clearance on 2004-04-19. The listed applicant is Accu-Stat Diagnostics, Inc.. The 510(k) number is K040327.

When did ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC) receive FDA 510(k) clearance?

ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC) received FDA 510(k) clearance on 2004-04-19, under 510(k) number K040327.

Who is the listed applicant for ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC)?

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

What is the FDA product code for ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC)?

The FDA product code for ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC) is MVO.

Related Clinical Trials

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.

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Other records listing Accu-Stat Diagnostics, 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.

K041221ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MAMP), ECSTASYK040629ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE

Related Devices (Code: MVO)

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.

K030447AT HOME DRUG CUP, MODEL 9150XPhamatechK014192LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS METPrinceton BioMeditech Corp.K013778PEACE OF MIND HOME DRUG TESTAdvantage Diagnostics Corp.K013409AT HOME DRUG TEST, MODEL 9074Phamatech, Inc.K013412AT HOME DRUG TEST, MODEL 9069Phamatech, Inc.K013410AT HOME DRUG TEST, MODEL 9064Phamatech, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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