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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioassay, vitamin b12
510(k) Number K030655
Device Name HOLOTC RIA
Applicant
AXIS-SHIELD BIOCHEMICALS, ASA
P.O. BOX 262069
SAN DIEGO,  CA  92196
Applicant Contact RONALD G LEONARDI
Correspondent
AXIS-SHIELD BIOCHEMICALS, ASA
P.O. BOX 262069
SAN DIEGO,  CA  92196
Correspondent Contact RONALD G LEONARDI
Regulation Number862.1810
Classification Product Code
CDD  
Subsequent Product Codes
JIS   JJX  
Date Received03/03/2003
Decision Date 01/29/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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