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FDA 510(k)

AMEDITECH DRUGSMARTCUP

K-Number: K053175 · 2005-12-08

ApplicantAmeditech, Inc.
Decision Date2005-12-08
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMEDITECH DRUGSMARTCUP is the device name listed in this FDA 510(k) record. The listed applicant is Ameditech, Inc.. It received FDA 510(k) clearance on 2005-12-08 under 510(k) number K053175. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMEDITECH DRUGSMARTCUP?

AMEDITECH DRUGSMARTCUP is a medical device that received FDA 510(k) clearance on 2005-12-08. The listed applicant is Ameditech, Inc.. The 510(k) number is K053175.

When did AMEDITECH DRUGSMARTCUP receive FDA 510(k) clearance?

AMEDITECH DRUGSMARTCUP received FDA 510(k) clearance on 2005-12-08, under 510(k) number K053175.

Who is the listed applicant for AMEDITECH DRUGSMARTCUP?

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 DRUGSMARTCUP?

The FDA product code for AMEDITECH DRUGSMARTCUP is DKZ.

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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/COC150K050186AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL IIIK042975AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL IIK040092AMEDITECH IMMU TEST DRUG SCREEN PANEL

View all 14 devices →

Related Devices (Code: DKZ)

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.

K240670DRI Ecstasy Plus AssayMicrogenics CorporationK233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel RxHangzhou AllTest Biotech Co., Ltd.K231137Xenta Drug Screen Cup, Xenta Drug Screen DipcardXenta Biomedical Science Co., Ltd.K200363Quidel Triage® TOX Drug Screen, 94600Quidel Cardiovascular, Inc.K191099Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test PanelAtlas MedicalK182719Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProQuidel Cardiovascular, 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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