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FDA 510(k)

STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541

K-Number: K000399 · 2000-05-15

ApplicantOraSure Technologies, Inc.
Decision Date2000-05-15
Product CodeLCM
DecisionSubstantially Equivalent

Device Summary

STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541 is the device name listed in this FDA 510(k) record. The listed applicant is OraSure Technologies, Inc.. It received FDA 510(k) clearance on 2000-05-15 under 510(k) number K000399. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541?

STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541 is a medical device that received FDA 510(k) clearance on 2000-05-15. The listed applicant is OraSure Technologies, Inc.. The 510(k) number is K000399.

When did STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541 receive FDA 510(k) clearance?

STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541 received FDA 510(k) clearance on 2000-05-15, under 510(k) number K000399.

Who is the listed applicant for STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541?

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

What is the FDA product code for STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541?

The FDA product code for STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541 is LCM.

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Other records listing OraSure Technologies, Inc. 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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