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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 K081150
Device Name RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST
Applicant
TURKLAB MEDICAL DEVICES INC
10040 SK. ATATURK ORGANIZE
SANAYI BOLGESI CIGLI
IZMIR,,  TR 35100
Applicant Contact HILDA CIL
Correspondent
TURKLAB MEDICAL DEVICES INC
10040 SK. ATATURK ORGANIZE
SANAYI BOLGESI CIGLI
IZMIR,,  TR 35100
Correspondent Contact HILDA CIL
Regulation Number862.1155
Classification Product Code
LCX  
Subsequent Product Code
JHI  
Date Received04/23/2008
Decision Date 06/16/2009
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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