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FDA 510(k)

MICROLINE SCREEN FOR PHENCYCLIDINE

K-Number: K921651 · 1992-07-08

ApplicantDrug Screening Systems, Inc.
Decision Date1992-07-08
Product CodeLCM
DecisionSubstantially Equivalent

Device Summary

MICROLINE SCREEN FOR PHENCYCLIDINE is the device name listed in this FDA 510(k) record. The listed applicant is Drug Screening Systems, Inc.. It received FDA 510(k) clearance on 1992-07-08 under 510(k) number K921651. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROLINE SCREEN FOR PHENCYCLIDINE?

MICROLINE SCREEN FOR PHENCYCLIDINE is a medical device that received FDA 510(k) clearance on 1992-07-08. The listed applicant is Drug Screening Systems, Inc.. The 510(k) number is K921651.

When did MICROLINE SCREEN FOR PHENCYCLIDINE receive FDA 510(k) clearance?

MICROLINE SCREEN FOR PHENCYCLIDINE received FDA 510(k) clearance on 1992-07-08, under 510(k) number K921651.

Who is the listed applicant for MICROLINE SCREEN FOR PHENCYCLIDINE?

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

What is the FDA product code for MICROLINE SCREEN FOR PHENCYCLIDINE?

The FDA product code for MICROLINE SCREEN FOR PHENCYCLIDINE is LCM.

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Other records listing Drug Screening Systems, 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.

K945829MICROLINE SCREEN FOR BENZODIAZEPINEK935052MICROLINE SCREEN FOR AMPHETAMINEK933480MICROLINE SCREEN FOR BARBITURATESK914915MICROLINE SCREEN FOR CANNABINOIDK911652MIRCOLINE SCREEN FOR COCAINEK910525MICROLINE SCREEN FOR METHAMPHETAMINE

View all 8 devices →

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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