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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 K965186
Device Name AXSYM B12
Applicant
ABBOTT LABORATORIES
DEPT 49C, BLDG. AP31
200 ABBOTT RD.
ABBOTT PARK,  IL  60064 -3537
Applicant Contact LAURA L GRANITZ
Correspondent
ABBOTT LABORATORIES
DEPT 49C, BLDG. AP31
200 ABBOTT RD.
ABBOTT PARK,  IL  60064 -3537
Correspondent Contact LAURA L GRANITZ
Regulation Number862.1810
Classification Product Code
CDD  
Date Received12/24/1996
Decision Date 03/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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