510(k) K151566

Abbott ARCHITECT Total T4 Calibrators by Abbott Laboratories — Product Code JIT

K151566 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "Abbott ARCHITECT Total T4 Calibrators". The FDA issued a decision of Substantially Equivalent on July 10, 2015. The device falls under product code JIT (Calibrator, Secondary), 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
July 10, 2015
Date Received
June 10, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Secondary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type