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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
Applicant
ABBOTT LABORATORIES
1920 HURD DR.
IRVING,  TX  75038
Applicant Contact MARK LITTLEFIELD
Correspondent
ABBOTT LABORATORIES
1920 HURD DR.
IRVING,  TX  75038
Correspondent Contact MARK LITTLEFIELD
Regulation Number862.1150
Classification Product Code
JIX  
Date Received05/14/1998
Decision Date 07/09/1998
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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