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FDA 510(k)

AT HOME DRUG TEST MODELS, 9308T AND 9308X

K-Number: K070009 · 2007-12-07

ApplicantPhamatech, Inc.
Decision Date2007-12-07
Product CodeDIS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AT HOME DRUG TEST MODELS, 9308T AND 9308X is the device name listed in this FDA 510(k) record. The listed applicant is Phamatech, Inc.. It received FDA 510(k) clearance on 2007-12-07 under 510(k) number K070009. The device is classified under product code DIS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AT HOME DRUG TEST MODELS, 9308T AND 9308X?

AT HOME DRUG TEST MODELS, 9308T AND 9308X is a medical device that received FDA 510(k) clearance on 2007-12-07. The listed applicant is Phamatech, Inc.. The 510(k) number is K070009.

When did AT HOME DRUG TEST MODELS, 9308T AND 9308X receive FDA 510(k) clearance?

AT HOME DRUG TEST MODELS, 9308T AND 9308X received FDA 510(k) clearance on 2007-12-07, under 510(k) number K070009.

Who is the listed applicant for AT HOME DRUG TEST MODELS, 9308T AND 9308X?

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 MODELS, 9308T AND 9308X?

The FDA product code for AT HOME DRUG TEST MODELS, 9308T AND 9308X is DIS.

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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 SCK043599MOMENTS MENOPAUSE CHECK, MODEL 9113K043051QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121K043167PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X

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Related Devices (Code: DIS)

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.

K161714Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis CorporationK092268RANDOX BARITURATES ASSAYRandox Laboratories, Ltd.K110515UCP DRUG SCREENING TEST CUPSUcp Biosciences, Inc.K070098QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SCPhamatech, Inc.K062165VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERSOrtho-Clinical DiagnosticsK050024ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYSGuangzhou Wondfo Biotech Co., Ltd.

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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