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FDA 510(k)

AMEDITECH IMMUTEST DRUG SCREEN PCP

K-Number: K012582 · 2001-11-30

ApplicantAmeditech, Inc.
Decision Date2001-11-30
Product CodeLCM
DecisionSubstantially Equivalent

Device Summary

AMEDITECH IMMUTEST DRUG SCREEN PCP is the device name listed in this FDA 510(k) record. The listed applicant is Ameditech, Inc.. It received FDA 510(k) clearance on 2001-11-30 under 510(k) number K012582. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMEDITECH IMMUTEST DRUG SCREEN PCP?

AMEDITECH IMMUTEST DRUG SCREEN PCP is a medical device that received FDA 510(k) clearance on 2001-11-30. The listed applicant is Ameditech, Inc.. The 510(k) number is K012582.

When did AMEDITECH IMMUTEST DRUG SCREEN PCP receive FDA 510(k) clearance?

AMEDITECH IMMUTEST DRUG SCREEN PCP received FDA 510(k) clearance on 2001-11-30, under 510(k) number K012582.

Who is the listed applicant for AMEDITECH IMMUTEST DRUG SCREEN PCP?

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

What is the FDA product code for AMEDITECH IMMUTEST DRUG SCREEN PCP?

The FDA product code for AMEDITECH IMMUTEST DRUG SCREEN PCP is LCM.

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Other records listing Ameditech, 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.

K113501AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)K113046AMEDITECH IMMUTEST MILTI-DRUG SCREENK063015AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150K053175AMEDITECH DRUGSMARTCUPK050186AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL IIIK042975AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II

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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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