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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
Recalls CDRH Recalls
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