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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK043443
Test Name Clarity Diagnostics LLC, Clarity Midstream Pregnancy Test  
Manufacturer NameGuangzhou Wondfo Biotech Co., Ltd.
Consumer Information Phone Number(877)485-7877
Test TypeUrine hCG by visual color comparison tests
Effective Date10/19/2021
Device Classification Name kit, test, pregnancy, hcg, over the counter
510(k) Number K043443
Device Name ONE STEP HCG URINE PREGNANCY TEST
Applicant
Guangzhou Wondfo Biotech Co., Ltd.
8903 SPRUCE MILL DRIVE
YARDLEY,  PA  19087
Applicant Contact HOWARD MANN
Correspondent
Guangzhou Wondfo Biotech Co., Ltd.
8903 SPRUCE MILL DRIVE
YARDLEY,  PA  19087
Correspondent Contact HOWARD MANN
Regulation Number862.1155
Classification Product Code
LCX  
Subsequent Product Code
JHI  
Date Received12/14/2004
Decision Date 04/08/2005
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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