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FDA 510(k)

ACCUSIGN, BIOSIGN PCP

K-Number: K961266 · 1996-05-31

ApplicantPrinceton BioMeditech Corp.
Decision Date1996-05-31
Product CodeLCM
DecisionSubstantially Equivalent

Device Summary

ACCUSIGN, BIOSIGN PCP is the device name listed in this FDA 510(k) record. The listed applicant is Princeton BioMeditech Corp.. It received FDA 510(k) clearance on 1996-05-31 under 510(k) number K961266. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUSIGN, BIOSIGN PCP?

ACCUSIGN, BIOSIGN PCP is a medical device that received FDA 510(k) clearance on 1996-05-31. The listed applicant is Princeton BioMeditech Corp.. The 510(k) number is K961266.

When did ACCUSIGN, BIOSIGN PCP receive FDA 510(k) clearance?

ACCUSIGN, BIOSIGN PCP received FDA 510(k) clearance on 1996-05-31, under 510(k) number K961266.

Who is the listed applicant for ACCUSIGN, BIOSIGN PCP?

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

What is the FDA product code for ACCUSIGN, BIOSIGN PCP?

The FDA product code for ACCUSIGN, BIOSIGN PCP is LCM.

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Other records listing Princeton BioMeditech Corp. as applicant

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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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