510(k) K123372

ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR by Abbott Laboratories — Product Code JIX

K123372 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR". The FDA issued a decision of Substantially Equivalent on January 14, 2013. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. Abbott Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2013
Date Received
November 1, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Multi-Analyte Mixture
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type