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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K050305
Device Name ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM, MODELS BM-1-1, BM-1-2, BM-1-3, BM-2-1, BM-2-2
Applicant
Bioscreen Medical, Inc.
Rr I Box 1045a
Mildred,  PA  18632
Applicant Contact JIMMY LIANG
Correspondent
Bioscreen Medical, Inc.
Rr I Box 1045a
Mildred,  PA  18632
Correspondent Contact JIMMY LIANG
Regulation Number862.1155
Classification Product Code
LCX  
Subsequent Product Code
JHI  
Date Received02/08/2005
Decision Date 05/23/2005
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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