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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Thyroid-Stimulating Hormone
510(k) Number K935049
Device Name ELEGANCE NEONATAL TSH ELISA
Applicant
Bioclone Australia Pty , Ltd.
1920 N St., NW Suite 650
Washington,  DC  20036
Applicant Contact BRUCE F MACKLER
Correspondent
Bioclone Australia Pty , Ltd.
1920 N St., NW Suite 650
Washington,  DC  20036
Correspondent Contact BRUCE F MACKLER
Regulation Number862.1690
Classification Product Code
JLW  
Date Received10/20/1993
Decision Date 10/03/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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