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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radioimmunoassay Systems, For Clinical Use
510(k) Number K983617
Device Name 25-HYDROXYVITAMIN D 125I RIA KIT
Applicant
DiaSorin, Inc.
9175 Guiford Rd.
Columbia,  MD  21046
Applicant Contact JUDITH J SMITH
Correspondent
DiaSorin, Inc.
9175 Guiford Rd.
Columbia,  MD  21046
Correspondent Contact JUDITH J SMITH
Regulation Number862.2050
Classification Product Code
LCI  
Date Received10/15/1998
Decision Date 11/16/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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