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FDA 510(k)

AT HOME DRUG TEST, MODEL 9064

K-Number: K013410 · 2001-12-06

ApplicantPhamatech, Inc.
Decision Date2001-12-06
Product CodeMVO
DecisionSubstantially Equivalent

Device Summary

AT HOME DRUG TEST, MODEL 9064 is the device name listed in this FDA 510(k) record. The listed applicant is Phamatech, Inc.. It received FDA 510(k) clearance on 2001-12-06 under 510(k) number K013410. The device is classified under product code MVO. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AT HOME DRUG TEST, MODEL 9064?

AT HOME DRUG TEST, MODEL 9064 is a medical device that received FDA 510(k) clearance on 2001-12-06. The listed applicant is Phamatech, Inc.. The 510(k) number is K013410.

When did AT HOME DRUG TEST, MODEL 9064 receive FDA 510(k) clearance?

AT HOME DRUG TEST, MODEL 9064 received FDA 510(k) clearance on 2001-12-06, under 510(k) number K013410.

Who is the listed applicant for AT HOME DRUG TEST, MODEL 9064?

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

What is the FDA product code for AT HOME DRUG TEST, MODEL 9064?

The FDA product code for AT HOME DRUG TEST, MODEL 9064 is MVO.

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Other records listing Phamatech, 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.

K181945QuickScreen Pro Multi Drug Screening Test, Model 9395ZK103295QUICKSCREEN COCAINE 150 SCREENING TESTK070098QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SCK070009AT HOME DRUG TEST MODELS, 9308T AND 9308XK043599MOMENTS MENOPAUSE CHECK, MODEL 9113K043051QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121

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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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