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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, luteinizing hormone
510(k) Number K942638
Device Name SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
13 MOUNTAIN VIEW AVE.
ORANGEBURG,  NY  10962
Applicant Contact KATHY BIEHL
Correspondent
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
13 MOUNTAIN VIEW AVE.
ORANGEBURG,  NY  10962
Correspondent Contact KATHY BIEHL
Regulation Number862.1485
Classification Product Code
CEP  
Subsequent Product Code
CGJ  
Date Received06/03/1994
Decision Date 09/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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