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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact HOWARD MANN
Regulation Number862.1155
Classification Product Code
DHA  
Date Received09/05/2007
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
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