FDA 510(k)

HOMECHECK MULTIPLE DRUG CUP TEST

K-Number: K071489 · 2008-03-28

ApplicantTianjin New Bay Bioresearch Co., Ltd.

Decision Date2008-03-28

Product CodeDKZ

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

HOMECHECK MULTIPLE DRUG CUP 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 2008-03-28 under 510(k) number K071489. 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 HOMECHECK MULTIPLE DRUG CUP TEST?

HOMECHECK MULTIPLE DRUG CUP TEST is a medical device that received FDA 510(k) clearance on 2008-03-28. The listed applicant is Tianjin New Bay Bioresearch Co., Ltd.. The 510(k) number is K071489.

When did HOMECHECK MULTIPLE DRUG CUP TEST receive FDA 510(k) clearance?

HOMECHECK MULTIPLE DRUG CUP TEST received FDA 510(k) clearance on 2008-03-28, under 510(k) number K071489.

Who is the listed applicant for HOMECHECK MULTIPLE DRUG CUP 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 HOMECHECK MULTIPLE DRUG CUP TEST?

The FDA product code for HOMECHECK MULTIPLE DRUG CUP TEST is DKZ.

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Related Devices (Code: DKZ)

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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.