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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dye-indicator, ph (urinary, non-quantitative)
510(k) Number K822241
Device Name FOLATE/B12 DUO-BEAD RADIOASSAY
Applicant
ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
Correspondent
ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
Regulation Number862.1550
Classification Product Code
CEN  
Date Received07/27/1982
Decision Date 10/26/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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