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FDA 510(k)

BIONIKE AQ PHENCYCLIDINE (PCP) TEST

K-Number: K993945 · 1999-12-07

ApplicantBionike Laboratories, Inc.
Decision Date1999-12-07
Product CodeLCM
DecisionSubstantially Equivalent

Device Summary

BIONIKE AQ PHENCYCLIDINE (PCP) TEST is the device name listed in this FDA 510(k) record. The listed applicant is Bionike Laboratories, Inc.. It received FDA 510(k) clearance on 1999-12-07 under 510(k) number K993945. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIONIKE AQ PHENCYCLIDINE (PCP) TEST?

BIONIKE AQ PHENCYCLIDINE (PCP) TEST is a medical device that received FDA 510(k) clearance on 1999-12-07. The listed applicant is Bionike Laboratories, Inc.. The 510(k) number is K993945.

When did BIONIKE AQ PHENCYCLIDINE (PCP) TEST receive FDA 510(k) clearance?

BIONIKE AQ PHENCYCLIDINE (PCP) TEST received FDA 510(k) clearance on 1999-12-07, under 510(k) number K993945.

Who is the listed applicant for BIONIKE AQ PHENCYCLIDINE (PCP) TEST?

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

What is the FDA product code for BIONIKE AQ PHENCYCLIDINE (PCP) TEST?

The FDA product code for BIONIKE AQ PHENCYCLIDINE (PCP) TEST is LCM.

Related Clinical Trials

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.

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Other records listing Bionike Laboratories, 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.

K972384AQ ONE STEP COCAINE TESTK971841BIONIKE AQ ONE STEP CANNABINOIDS (THC) TESTK971361AQ OPIATES (MORPHINE) TESTK960992BIONIKE A/Q PREGNANCY TESTK954901BIONIKE A/Q PREGNANCY TEST

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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