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FDA 510(k)

ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS

K-Number: K061005 · 2006-10-04

ApplicantApplied Dna Technologies, Inc.
Decision Date2006-10-04
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS is the device name listed in this FDA 510(k) record. The listed applicant is Applied Dna Technologies, Inc.. It received FDA 510(k) clearance on 2006-10-04 under 510(k) number K061005. 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 ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS?

ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS is a medical device that received FDA 510(k) clearance on 2006-10-04. The listed applicant is Applied Dna Technologies, Inc.. The 510(k) number is K061005.

When did ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS receive FDA 510(k) clearance?

ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS received FDA 510(k) clearance on 2006-10-04, under 510(k) number K061005.

Who is the listed applicant for ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS?

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

What is the FDA product code for ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS?

The FDA product code for ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS is DKZ.

Related Clinical Trials

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Other records listing Applied Dna Technologies, 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.

K080467BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP, BAR, BZO, COC, MET, MTD, MOR, PCP, TCA, THC,K070921BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCGK071030BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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