HOME PREGNANCY TEST


Device Classification Name

visual, pregnancy hcg, prescription use

510(k) Number K112315
Device Name HOME PREGNANCY TEST
Applicant
NEWSCEN COAST BIO-PHARMACEUTICAL CO., LTD
2117 claney ct
simi valley, 
CA 
93065

Applicant Contact chandravadan patel
Correspondent
NEWSCEN COAST BIO-PHARMACEUTICAL CO., LTD
2117 claney ct
simi valley, 
CA 
93065

Correspodent Contact chandravadan patel
Regulation Number 862.1155
Classification Product Code
JHI  
Date Received 08/11/2011
Decision Date 04/23/2012
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