510(k) K955139

OLYMPUS UNSATURATED IRON BINDING CAPACITY REAGENT by Olympus America, Inc. — Product Code JMO

K955139 is an FDA 510(k) premarket notification submitted by Olympus America, Inc. for the device "OLYMPUS UNSATURATED IRON BINDING CAPACITY REAGENT". The FDA issued a decision of Substantially Equivalent on Feb 12, 1996. The device falls under product code JMO (Ferrozine (Colorimetric) Iron Binding Capacity), a Class I device regulated under 21 CFR 862.1415. Olympus America, Inc. has 148 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 12, 1996
Date Received
Nov 13, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Ferrozine (Colorimetric) Iron Binding Capacity
Device Class
Class I
Regulation Number
862.1415
Review Panel
CH
Submission Type
510(k) Exempt

Source: FDA 510(k) database entry for K955139. Report a data issue: hello@regdatalab.com.