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FDA 510(k)

AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C

K-Number: K994093 · 1999-12-16

ApplicantPhamatech
Decision Date1999-12-16
Product CodeLCL
DecisionSubstantially Equivalent

Device Summary

AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C is the device name listed in this FDA 510(k) record. The listed applicant is Phamatech. It received FDA 510(k) clearance on 1999-12-16 under 510(k) number K994093. The device is classified under product code LCL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C?

AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C is a medical device that received FDA 510(k) clearance on 1999-12-16. The listed applicant is Phamatech. The 510(k) number is K994093.

When did AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C receive FDA 510(k) clearance?

AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C received FDA 510(k) clearance on 1999-12-16, under 510(k) number K994093.

Who is the listed applicant for AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C?

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 WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C?

The FDA product code for AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C is LCL.

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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 TK010653AT HOME DRUG TEST, MODEL 9068 T

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Related Devices (Code: LCL)

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.

K011275PSYCHEMEDICS RIA PHENCYCLIDINE ASSAYPsychemedics Corp.K913864PCP DIRECT RIA KIT (I-125)Immunalysis CorporationK890882ABUSCREEN FP FOR PHENCYCLIDINERoche Diagnostic Systems, Inc.K882179EMIT HVA PHENCYCLIDINE ASSAYSyva Co.K880011REVISED LABELING FOR ADX PHENCYCLIDINEAbbott LaboratoriesK874626REVISED LABELING FOR SYVA PHENCYCLIDINE ASSAYSSyva Co.

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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