FDA 510(k)

FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DEVICE

K-Number: K052882 · 2006-02-15

ApplicantTianjin New Bay Bioresearch Co., Ltd.

Decision Date2006-02-15

Product CodeDKZ

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Tianjin New Bay Bioresearch Co., Ltd.. It received FDA 510(k) clearance on 2006-02-15 under 510(k) number K052882. 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 FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DEVICE?

FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DEVICE is a medical device that received FDA 510(k) clearance on 2006-02-15. The listed applicant is Tianjin New Bay Bioresearch Co., Ltd.. The 510(k) number is K052882.

When did FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DEVICE receive FDA 510(k) clearance?

FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DEVICE received FDA 510(k) clearance on 2006-02-15, under 510(k) number K052882.

Who is the listed applicant for FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DEVICE?

The FDA 510(k) record lists Tianjin New Bay Bioresearch Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DEVICE?

The FDA product code for FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DEVICE is DKZ.

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Other records listing Tianjin New Bay Bioresearch Co., Ltd. as applicant

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Related Devices (Code: DKZ)

K240670DRI Ecstasy Plus AssayMicrogenics Corporation K233019AllTest 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 Medical K182719Quidel 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.