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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
Recalls CDRH Recalls
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