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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name myoglobin, antigen, antiserum, control
510(k) Number K983848
Device Name ABBOTT AXSYM MYOGLOBIN
Applicant
ABBOTT LABORATORIES
200 ABBOTT PARK RD.
ABBOTT PARK,,  IL  60064 -3537
Applicant Contact LAURA L GRANITZ
Correspondent
ABBOTT LABORATORIES
200 ABBOTT PARK RD.
ABBOTT PARK,,  IL  60064 -3537
Correspondent Contact LAURA L GRANITZ
Regulation Number866.5680
Classification Product Code
DDR  
Date Received10/30/1998
Decision Date 11/16/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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