510(k) K873120

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

K873120 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ABBOTT A-GENT IRON REAGENT KIT". The FDA issued a decision of Substantially Equivalent on August 25, 1987. The device falls under product code CFM (Bathophenanthroline, Colorimetry, Iron (Non-Heme)), a Class I device regulated under 21 CFR 862.1410. Abbott Laboratories has at least 10 other 510(k) clearances on record.

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