510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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JMOClass I

Ferrozine (Colorimetric) Iron Binding Capacity

21 CFR 862.1415 / Clinical Chemistry
FDA source (opens on fda.gov)

JMO is the FDA product code for Ferrozine (Colorimetric) Iron Binding Capacity, a class I device type, regulated under 21 CFR 862.1415. As of , FDA records hold 46 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
JMO
Device name
Ferrozine (Colorimetric) Iron Binding Capacity
Regulation
21 CFR 862.1415
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
46
Ingested recalls
7

Clearances, product code JMO

By decision year
46 clearances under product code JMO with a decision year between 1977 and 2012, 1991 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code JMO by decision year
YearClearances
19772
19781
19832
19853
19861
19872
19883
19891
19902
19914
19922
19933
19951
19964
19984
19993
20002
20012
20041
20051
20061
20121

Applicants with the most clearances

Product code JMO
Applicants holding the most 510(k) clearances under product code JMO
ApplicantClearances
Abbott Medical4
Em Diagnostic Systems, Inc.3
J.S. Medical Assoc.3
A.P. Total Care, Inc.2
American Research Products Co.2
Data Medical Associates, Inc.2
Sekisui Diagnostics P.E.I. Inc.2
Harleco2
OLYMPUS Corporation of the Americas2
Ortho-Clinical Diagnostics, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 26 companies shown, in name order