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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK103574
Test Name Zhejiang Orient Gene Biotech Co. Pregnancy One Step Rapid Test (Cassette)  
Manufacturer NameLehnus & Associates Consulting
Consumer Information Phone Number1(866)982-3818
Test TypeUrine hCG by visual color comparison tests
Effective Date08/12/2011
Device Classification Name Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K103574
Device Name PREGNANCY ONE STEP RAPID TEST
Applicant
Lehnus & Associates Consulting
150 Cherry Lane Rd.
East Stroudsburg,  PA  18301 -8804
Applicant Contact Gary Lehnus
Correspondent
Lehnus & Associates Consulting
150 Cherry Lane Rd.
East Stroudsburg,  PA  18301 -8804
Correspondent Contact Gary Lehnus
Regulation Number862.1155
Classification Product Code
LCX  
Date Received12/06/2010
Decision Date 07/28/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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