ONE STEP HCG URINE/SERUM TEST


Device Classification Name

system, test, human chorionic gonadotropin

510(k) Number K072500
Device Name ONE STEP HCG URINE/SERUM TEST
Applicant
Guangzhou Wondfo Biotech Co., Ltd.
8903 spruce mill drive
yardley, 
PA 
19067

Applicant Contact howard mann
Correspondent
Guangzhou Wondfo Biotech Co., Ltd.
8903 spruce mill drive
yardley, 
PA 
19067

Correspodent Contact howard mann
Regulation Number 862.1155
Classification Product Code
DHA  
Date Received 09/05/2007
Decision Date 04/21/2009
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