FDA product code JMO: Ferrozine (Colorimetric) Iron Binding Capacity
JMO is the FDA product code for ferrozine (colorimetric) iron binding capacity. It is a Class I device, regulated under 21 CFR 862.1415 and reviewed by the Clinical Chemistry panel. FDA has cleared 46 510(k) submissions under JMO, from 30 different applicants. The average 510(k) review took 57 days (median 46). FDA has posted 7 recalls for JMO devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Ferrozine (Colorimetric) Iron Binding Capacity |
| Device class | Class I |
| Regulation | 21 CFR 862.1415 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JMO clearance
Top JMO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Laboratories | 4 | 1998-07-30 |
| J.S. Medical Assoc. | 3 | 1991-09-25 |
| Em Diagnostic Systems, Inc. | 3 | 1991-09-19 |
| Ortho-Clinical Diagnostics, Inc. | 2 | 2006-06-15 |
| Olympus America, Inc. | 2 | 2004-07-16 |
25 more applicants have JMO clearances. See the full list in Caduvo.
Most recent JMO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K113438 | Alfa Wassermann Diagnostic Technologies, Inc. | ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT | 2012-06-01 | 193 |
| K061464 | Ortho-Clinical Diagnostics, Inc. | VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668 | 2006-06-15 | 21 |
| K052867 | Ortho-Clinical Diagnostics, Inc. | VITROS CHEMISTRY PRODUCTS DTIBC REAGENT | 2005-12-23 | 73 |
| K041793 | Olympus America, Inc. | OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524 | 2004-07-16 | 14 |
| K013102 | Wiener Laboratories Saic | WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002 | 2001-11-13 | 57 |
Recalls for JMO devices
7 product recalls in 7 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-06-26.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2024 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code JMO?
JMO is the FDA product code for ferrozine (colorimetric) iron binding capacity. It is a Class I device, regulated under 21 CFR 862.1415 and reviewed by the Clinical Chemistry panel.
What device class is JMO?
Class I, regulation 21 CFR 862.1415. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JMO?
Across 46 cleared submissions the average was 57 days from receipt to decision (median 46).
Which companies have the most JMO clearances?
Abbott Laboratories (4); J.S. Medical Assoc. (3); Em Diagnostic Systems, Inc. (3); Ortho-Clinical Diagnostics, Inc. (2); Olympus America, Inc. (2).
Have JMO devices been recalled?
Yes: 7 product recalls across 7 recall events; the most recent began 2025-06-26.
Next steps
- Run an FDA pathway report with predicate devices for product code JMO
- Run a recall and safety report across every JMO manufacturer
- Watch product code JMO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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