QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST


Device Classification Name

kit, test, pregnancy, hcg, over the counter

510(k) Number K112449
Device Name QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST
Applicant
Tianjin New Bay Bioresearch Co., Ltd.
5230 via primaria
yorba linda, 
CA 
92886

Applicant Contact hann-ping wang
Correspondent
Tianjin New Bay Bioresearch Co., Ltd.
5230 via primaria
yorba linda, 
CA 
92886

Correspodent Contact hann-ping wang
Regulation Number 862.1155
Classification Product Code
LCX  
Date Received 08/25/2011
Decision Date 09/24/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No