FDA 510(k)

QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST

K-Number: K112449 · 2012-09-24

ApplicantTianjin New Bay Bioresearch Co., Ltd.

Decision Date2012-09-24

Product CodeLCX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY 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 2012-09-24 under 510(k) number K112449. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST?

QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST is a medical device that received FDA 510(k) clearance on 2012-09-24. The listed applicant is Tianjin New Bay Bioresearch Co., Ltd.. The 510(k) number is K112449.

When did QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST receive FDA 510(k) clearance?

QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST received FDA 510(k) clearance on 2012-09-24, under 510(k) number K112449.

Who is the listed applicant for QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY 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 QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST?

The FDA product code for QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST is LCX.

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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.