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FDA 510(k)

AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150

K-Number: K063015 · 2006-12-20

ApplicantAmeditech, Inc.
Decision Date2006-12-20
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150 is the device name listed in this FDA 510(k) record. The listed applicant is Ameditech, Inc.. It received FDA 510(k) clearance on 2006-12-20 under 510(k) number K063015. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150?

AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150 is a medical device that received FDA 510(k) clearance on 2006-12-20. The listed applicant is Ameditech, Inc.. The 510(k) number is K063015.

When did AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150 receive FDA 510(k) clearance?

AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150 received FDA 510(k) clearance on 2006-12-20, under 510(k) number K063015.

Who is the listed applicant for AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150?

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 MULTI-DRUG SCREEN BUP/PPX/COC150?

The FDA product code for AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150 is DJG.

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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 SCREENK053175AMEDITECH DRUGSMARTCUPK050186AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL IIIK042975AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL IIK040092AMEDITECH IMMU TEST DRUG SCREEN PANEL

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Related Devices (Code: DJG)

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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