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FDA 510(k)

ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST

K-Number: K981363 · 1998-12-22

ApplicantTcpi, Inc.
Decision Date1998-12-22
Product CodeLCM
DecisionSubstantially Equivalent

Device Summary

ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST is the device name listed in this FDA 510(k) record. The listed applicant is Tcpi, Inc.. It received FDA 510(k) clearance on 1998-12-22 under 510(k) number K981363. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST?

ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST is a medical device that received FDA 510(k) clearance on 1998-12-22. The listed applicant is Tcpi, Inc.. The 510(k) number is K981363.

When did ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST receive FDA 510(k) clearance?

ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST received FDA 510(k) clearance on 1998-12-22, under 510(k) number K981363.

Who is the listed applicant for ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST?

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

What is the FDA product code for ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST?

The FDA product code for ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST is LCM.

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Other records listing Tcpi, 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.

K972960HEALTH CHECK URI-TEST PROTEIN IN URINEK981197ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TESTK980776ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TESTK951853ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)K954968HEALTH CHECK URI-TEST GLUCOSE IN URINE TESTK954685URITEST - NITRITE IN URINE TEST

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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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