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FDA 510(k)

AT HOME DRUG TEST, MODEL 9068 T

K-Number: K010653 · 2001-04-05

ApplicantPhamatech
Decision Date2001-04-05
Product CodeMVO
DecisionSubstantially Equivalent

Device Summary

AT HOME DRUG TEST, MODEL 9068 T is the device name listed in this FDA 510(k) record. The listed applicant is Phamatech. It received FDA 510(k) clearance on 2001-04-05 under 510(k) number K010653. The device is classified under product code MVO. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AT HOME DRUG TEST, MODEL 9068 T?

AT HOME DRUG TEST, MODEL 9068 T is a medical device that received FDA 510(k) clearance on 2001-04-05. The listed applicant is Phamatech. The 510(k) number is K010653.

When did AT HOME DRUG TEST, MODEL 9068 T receive FDA 510(k) clearance?

AT HOME DRUG TEST, MODEL 9068 T received FDA 510(k) clearance on 2001-04-05, under 510(k) number K010653.

Who is the listed applicant for AT HOME DRUG TEST, MODEL 9068 T?

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

What is the FDA product code for AT HOME DRUG TEST, MODEL 9068 T?

The FDA product code for AT HOME DRUG TEST, MODEL 9068 T is MVO.

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Other records listing Phamatech 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.

K041578QUICKSCREEN, MODELS 9177X AND 9178XK030447AT HOME DRUG CUP, MODEL 9150XK010833AT WORK DRUG TEST, MODEL 9177T AWTK010836AT WORK DRUG TEST, MODEL 9147T AWTK010655AT HOME DRUG TESTT, MODEL 9150 TK010654AT HOME DRUG TEST, MODEL 9078 T

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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.

K040327ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC)Accu-Stat Diagnostics, Inc.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.

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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