FDA 510(k)

FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST

K-Number: K061617 · 2006-11-22

ApplicantTianjin New Bay Bioresearch Co., Ltd.

Decision Date2006-11-22

Product CodeDKZ

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST 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 2006-11-22 under 510(k) number K061617. 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 ONE STEP DIP & READ (X) DRUG SCREEN TEST?

FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST is a medical device that received FDA 510(k) clearance on 2006-11-22. The listed applicant is Tianjin New Bay Bioresearch Co., Ltd.. The 510(k) number is K061617.

When did FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST receive FDA 510(k) clearance?

FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST received FDA 510(k) clearance on 2006-11-22, under 510(k) number K061617.

Who is the listed applicant for FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST?

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 ONE STEP DIP & READ (X) DRUG SCREEN TEST?

The FDA product code for FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST is DKZ.

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Related Devices (Code: DKZ)

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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.