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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name calibrator, multi-analyte mixture
510(k) Number K981706
Device Name AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2
Original Applicant
ABBOTT LABORATORIES
1920 hurd dr.
irving,  TX  75038
Original Contact mark littlefield
Regulation Number862.1150
Classification Product Code
JIX  
Date Received05/14/1998
Decision Date 07/09/1998
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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