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FDA 510(k)

QUICKSCREEN ONE STEP PCP SCREENING TEST

K-Number: K974582 · 1998-02-04

ApplicantPhamatech
Decision Date1998-02-04
Product CodeLCM
DecisionSubstantially Equivalent

Device Summary

QUICKSCREEN ONE STEP PCP SCREENING TEST is the device name listed in this FDA 510(k) record. The listed applicant is Phamatech. It received FDA 510(k) clearance on 1998-02-04 under 510(k) number K974582. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUICKSCREEN ONE STEP PCP SCREENING TEST?

QUICKSCREEN ONE STEP PCP SCREENING TEST is a medical device that received FDA 510(k) clearance on 1998-02-04. The listed applicant is Phamatech. The 510(k) number is K974582.

When did QUICKSCREEN ONE STEP PCP SCREENING TEST receive FDA 510(k) clearance?

QUICKSCREEN ONE STEP PCP SCREENING TEST received FDA 510(k) clearance on 1998-02-04, under 510(k) number K974582.

Who is the listed applicant for QUICKSCREEN ONE STEP PCP SCREENING TEST?

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 QUICKSCREEN ONE STEP PCP SCREENING TEST?

The FDA product code for QUICKSCREEN ONE STEP PCP SCREENING TEST is LCM.

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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: LCM)

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.

K212952Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in HairPsychemedics CorporationK203489SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis CorporationK181135Immunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis CorporationK163220Atellica CH Phencyclidine (Pcp)Siemens Healthcare Diagnostics, Inc.K131181OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINEOmega Laboratories, Inc.K122703RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTORBiophor Diagnostics, 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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