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FDA 510(k)

ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP)

K-Number: K895906 · 1990-01-26

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1990-01-26
Product CodeLCM
DecisionSubstantially Equivalent

Device Summary

ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP) is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1990-01-26 under 510(k) number K895906. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP)?

ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP) is a medical device that received FDA 510(k) clearance on 1990-01-26. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K895906.

When did ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP) receive FDA 510(k) clearance?

ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP) received FDA 510(k) clearance on 1990-01-26, under 510(k) number K895906.

Who is the listed applicant for ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP)?

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

What is the FDA product code for ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP)?

The FDA product code for ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP) is LCM.

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Other records listing Roche Diagnostic 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.

K983698MODIFICATION TO ABUSCREEN ONLINE BARBITURATESK983702MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINESK983704MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINEK983556ABUSCREEN ONLINE BENZ 300 CALIBRATORSK983555ABUSCREEN ONLINE BENZ 200 CALIBRATORSK983700MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE

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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

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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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