FDA product code CFM: Bathophenanthroline, Colorimetry, Iron (Non-Heme)
CFM is the FDA product code for bathophenanthroline, colorimetry, iron (non-heme). It is a Class I device, regulated under 21 CFR 862.1410 and reviewed by the Clinical Chemistry panel. FDA has cleared 21 510(k) submissions under CFM, from 15 different applicants. The average 510(k) review took 40 days (median 35).
Classification
| Field | Value |
|---|---|
| Device name | Bathophenanthroline, Colorimetry, Iron (Non-Heme) |
| Device class | Class I |
| Regulation | 21 CFR 862.1410 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CFM clearance
Top CFM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Laboratories | 3 | 1998-06-08 |
| Wako Chemicals USA, Inc. | 2 | 1999-01-15 |
| Synermed, Inc. | 2 | 1991-07-30 |
| Data Medical Associates, Inc. | 2 | 1986-05-23 |
| Diagnostic Chemicals, Ltd. (Usa) | 2 | 1984-08-07 |
10 more applicants have CFM clearances. See the full list in Caduvo.
Most recent CFM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K984119 | Wako Chemicals USA, Inc. | WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR | 1999-01-15 | 58 |
| K981581 | Abbott Laboratories | IRON | 1998-06-08 | 35 |
| K932871 | Catachem, Inc. | UIBC FOR DISCREET RANDOM ACCESS ANALYZER | 1993-09-08 | 86 |
| K913705 | Em Diagnostic Systems, Inc. | ABBOTT QLUICKSTART IRON TEST, ITEM #5A29 | 1991-10-09 | 51 |
| K912912 | Synermed, Inc. | SYNERMED SERUM IRON-600 REAGENT KIT | 1991-07-30 | 27 |
Recalls for CFM devices
openFDA lists no recalls for product code CFM.
Frequently asked questions
What is FDA product code CFM?
CFM is the FDA product code for bathophenanthroline, colorimetry, iron (non-heme). It is a Class I device, regulated under 21 CFR 862.1410 and reviewed by the Clinical Chemistry panel.
What device class is CFM?
Class I, regulation 21 CFR 862.1410. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CFM?
Across 21 cleared submissions the average was 40 days from receipt to decision (median 35).
Which companies have the most CFM clearances?
Abbott Laboratories (3); Wako Chemicals USA, Inc. (2); Synermed, Inc. (2); Data Medical Associates, Inc. (2); Diagnostic Chemicals, Ltd. (Usa) (2).
Next steps
- Run an FDA pathway report with predicate devices for product code CFM
- Run a recall and safety report across every CFM manufacturer
- Watch product code CFM 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.
All Clinical Chemistry product codes · FDA product code lookup · 510(k) database search · 510(k) review times