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FDA 510(k)

ACON MULTI-CLIN DRUG SCREEN TEST DEVICE

K-Number: K041685 · 2004-08-30

ApplicantACON Laboratories, Inc.
Decision Date2004-08-30
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACON MULTI-CLIN DRUG SCREEN TEST DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2004-08-30 under 510(k) number K041685. 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 ACON MULTI-CLIN DRUG SCREEN TEST DEVICE?

ACON MULTI-CLIN DRUG SCREEN TEST DEVICE is a medical device that received FDA 510(k) clearance on 2004-08-30. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K041685.

When did ACON MULTI-CLIN DRUG SCREEN TEST DEVICE receive FDA 510(k) clearance?

ACON MULTI-CLIN DRUG SCREEN TEST DEVICE received FDA 510(k) clearance on 2004-08-30, under 510(k) number K041685.

Who is the listed applicant for ACON MULTI-CLIN DRUG SCREEN TEST DEVICE?

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

What is the FDA product code for ACON MULTI-CLIN DRUG SCREEN TEST DEVICE?

The FDA product code for ACON MULTI-CLIN DRUG SCREEN TEST DEVICE is DKZ.

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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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