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FDA 510(k)

AUTO-LYTE PCP EIA, MODEL #1254U

K-Number: K982801 · 1998-11-04

ApplicantOraSure Technologies, Inc.
Decision Date1998-11-04
Product CodeLCM
DecisionSubstantially Equivalent

Device Summary

AUTO-LYTE PCP EIA, MODEL #1254U 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 1998-11-04 under 510(k) number K982801. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTO-LYTE PCP EIA, MODEL #1254U?

AUTO-LYTE PCP EIA, MODEL #1254U is a medical device that received FDA 510(k) clearance on 1998-11-04. The listed applicant is OraSure Technologies, Inc.. The 510(k) number is K982801.

When did AUTO-LYTE PCP EIA, MODEL #1254U receive FDA 510(k) clearance?

AUTO-LYTE PCP EIA, MODEL #1254U received FDA 510(k) clearance on 1998-11-04, under 510(k) number K982801.

Who is the listed applicant for AUTO-LYTE PCP EIA, MODEL #1254U?

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 AUTO-LYTE PCP EIA, MODEL #1254U?

The FDA product code for AUTO-LYTE PCP EIA, MODEL #1254U 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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