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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name acid, folic, radioimmunoassay
510(k) Number K972232
Device Name ABBOTT AXSYM FOLATE
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 Number862.1295
Classification Product Code
CGN  
Date Received06/16/1997
Decision Date 06/24/1997
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
Recalls CDRH Recalls
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