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FDA 510(k)

AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II

K-Number: K042975 · 2004-12-29

ApplicantAmeditech, Inc.
Decision Date2004-12-29
Product CodeDIS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II is the device name listed in this FDA 510(k) record. The listed applicant is Ameditech, Inc.. It received FDA 510(k) clearance on 2004-12-29 under 510(k) number K042975. The device is classified under product code DIS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II?

AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II is a medical device that received FDA 510(k) clearance on 2004-12-29. The listed applicant is Ameditech, Inc.. The 510(k) number is K042975.

When did AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II receive FDA 510(k) clearance?

AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II received FDA 510(k) clearance on 2004-12-29, under 510(k) number K042975.

Who is the listed applicant for AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II?

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 PANEL II?

The FDA product code for AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II is DIS.

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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 IIIK040092AMEDITECH IMMU TEST DRUG SCREEN PANEL

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Related Devices (Code: DIS)

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.

K161714Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis CorporationK092268RANDOX BARITURATES ASSAYRandox Laboratories, Ltd.K110515UCP DRUG SCREENING TEST CUPSUcp Biosciences, Inc.K070098QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SCPhamatech, Inc.K070009AT HOME DRUG TEST MODELS, 9308T AND 9308XPhamatech, Inc.K062165VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERSOrtho-Clinical Diagnostics

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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