510(k) K934312

AXSYM(TM) T-UPTAKE by Abbott Laboratories — Product Code KHQ

K934312 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "AXSYM(TM) T-UPTAKE". The FDA issued a decision of Substantially Equivalent on June 21, 1994. The device falls under product code KHQ (Radioassay, Triiodothyronine Uptake), a Class II device regulated under 21 CFR 862.1715. Abbott Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1994
Date Received
September 1, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioassay, Triiodothyronine Uptake
Device Class
Class II
Regulation Number
862.1715
Review Panel
CH
Submission Type