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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Estradiol
510(k) Number K041349
Device Name LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM
Applicant
Ibl GmbH
150 Cherry Lane Rd.
East Stroudsburg,  PA  18301
Applicant Contact Gary Lehnus
Correspondent
Ibl GmbH
150 Cherry Lane Rd.
East Stroudsburg,  PA  18301
Correspondent Contact Gary Lehnus
Regulation Number862.1260
Classification Product Code
CHP  
Date Received05/20/2004
Decision Date 09/24/2004
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
Predetermined Change
Control Plan Authorized		 No
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