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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Parathyroid Hormone
510(k) Number K000471
Device Name FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT
Applicant
Future Diagnostics B.V.
4079 Mt. Barnard
San Diego,  CA  92111
Applicant Contact DAVE D SMITH
Correspondent
Future Diagnostics B.V.
4079 Mt. Barnard
San Diego,  CA  92111
Correspondent Contact DAVE D SMITH
Regulation Number862.1545
Classification Product Code
CEW  
Date Received02/14/2000
Decision Date 04/11/2000
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
Recalls CDRH Recalls
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