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FDA 510(k)

ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2

K-Number: K994020 · 2000-01-27

ApplicantRoche Diagnostics Corp.
Decision Date2000-01-27
Product CodeLCM
DecisionSubstantially Equivalent

Device Summary

ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2000-01-27 under 510(k) number K994020. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2?

ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2 is a medical device that received FDA 510(k) clearance on 2000-01-27. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K994020.

When did ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2 receive FDA 510(k) clearance?

ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2 received FDA 510(k) clearance on 2000-01-27, under 510(k) number K994020.

Who is the listed applicant for ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2?

The FDA 510(k) record lists Roche Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2?

The FDA product code for ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2 is LCM.

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Related Devices (Code: LCM)

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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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