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FDA 510(k)

REDI-TEST PCP

K-Number: K991698 · 1999-08-25

ApplicantRedwood Biotech, Inc.
Decision Date1999-08-25
Product CodeLCM
DecisionSubstantially Equivalent

Device Summary

REDI-TEST PCP is the device name listed in this FDA 510(k) record. The listed applicant is Redwood Biotech, Inc.. It received FDA 510(k) clearance on 1999-08-25 under 510(k) number K991698. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REDI-TEST PCP?

REDI-TEST PCP is a medical device that received FDA 510(k) clearance on 1999-08-25. The listed applicant is Redwood Biotech, Inc.. The 510(k) number is K991698.

When did REDI-TEST PCP receive FDA 510(k) clearance?

REDI-TEST PCP received FDA 510(k) clearance on 1999-08-25, under 510(k) number K991698.

Who is the listed applicant for REDI-TEST PCP?

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

What is the FDA product code for REDI-TEST PCP?

The FDA product code for REDI-TEST PCP is LCM.

Other records listing Redwood Biotech, 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.

K000979REDI-SCREENK993100REDI-SCREENK991110REDI-TEST COCAINEK991504REDI-TEST METHAMPHETAMINEK990870REDI-TEST THC

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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