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FDA 510(k)

ORAL FLUID PHENCYCLIDINE

K-Number: K093989 · 2011-01-25

ApplicantRoche Diagnostics
Decision Date2011-01-25
Product CodeLCM
DecisionSubstantially Equivalent

Device Summary

ORAL FLUID PHENCYCLIDINE is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2011-01-25 under 510(k) number K093989. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORAL FLUID PHENCYCLIDINE?

ORAL FLUID PHENCYCLIDINE is a medical device that received FDA 510(k) clearance on 2011-01-25. The listed applicant is Roche Diagnostics. The 510(k) number is K093989.

When did ORAL FLUID PHENCYCLIDINE receive FDA 510(k) clearance?

ORAL FLUID PHENCYCLIDINE received FDA 510(k) clearance on 2011-01-25, under 510(k) number K093989.

Who is the listed applicant for ORAL FLUID PHENCYCLIDINE?

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

What is the FDA product code for ORAL FLUID PHENCYCLIDINE?

The FDA product code for ORAL FLUID PHENCYCLIDINE is LCM.

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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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