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FDA 510(k)

AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINE

K-Number: K012585 · 2001-11-16

ApplicantAmeditech, Inc.
Decision Date2001-11-16
Product CodeLAF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINE is the device name listed in this FDA 510(k) record. The listed applicant is Ameditech, Inc.. It received FDA 510(k) clearance on 2001-11-16 under 510(k) number K012585. The device is classified under product code LAF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINE?

AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINE is a medical device that received FDA 510(k) clearance on 2001-11-16. The listed applicant is Ameditech, Inc.. The 510(k) number is K012585.

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

AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINE received FDA 510(k) clearance on 2001-11-16, under 510(k) number K012585.

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

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 METHAMPHETAMINE?

The FDA product code for AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINE is LAF.

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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: LAF)

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.

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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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