510(k) K873120

ABBOTT A-GENT IRON REAGENT KIT by Abbott Laboratories — Product Code CFM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1987
Date Received
August 10, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bathophenanthroline, Colorimetry, Iron (Non-Heme)
Device Class
Class I
Regulation Number
862.1410
Review Panel
CH
Submission Type