FDA product code CFH: Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
CFH is the FDA product code for tetrazolium int dye-diaphorase, lactate dehydrogenase. It is a Class II device, regulated under 21 CFR 862.1440 and reviewed by the Clinical Chemistry panel. FDA has cleared 13 510(k) submissions under CFH, from 12 different applicants. The average 510(k) review took 54 days (median 40).
Classification
| Field | Value |
|---|---|
| Device name | Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase |
| Device class | Class II |
| Regulation | 21 CFR 862.1440 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CFH clearance
Top CFH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hycel, Inc. | 2 | 1979-01-26 |
| Arkray, Inc. | 1 | 2005-06-06 |
| Careside, Inc. | 1 | 2002-07-03 |
| Heraeus Kulzer, Inc. | 1 | 1989-10-19 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1989-10-17 |
7 more applicants have CFH clearances. See the full list in Caduvo.
Most recent CFH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K050790 | Arkray, Inc. | SPOTCHEM II LDH TEST | 2005-06-06 | 70 |
| K020484 | Careside, Inc. | CARESIDE LDH | 2002-07-03 | 140 |
| K895138 | Heraeus Kulzer, Inc. | CLINISTAT LDH REAGENT TEST | 1989-10-19 | 64 |
| K894578 | Bd Becton Dickinson Vacutainer Systems Preanalytic | IQ LDH | 1989-10-17 | 85 |
| K880630 | Tech-Co, Inc. | LACTATE DEHYDROGENASE (LDH-L) | 1988-03-16 | 29 |
Recalls for CFH devices
openFDA lists no recalls for product code CFH.
Frequently asked questions
What is FDA product code CFH?
CFH is the FDA product code for tetrazolium int dye-diaphorase, lactate dehydrogenase. It is a Class II device, regulated under 21 CFR 862.1440 and reviewed by the Clinical Chemistry panel.
What device class is CFH?
Class II, regulation 21 CFR 862.1440. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CFH?
Across 13 cleared submissions the average was 54 days from receipt to decision (median 40).
Which companies have the most CFH clearances?
Hycel, Inc. (2); Arkray, Inc. (1); Careside, Inc. (1); Heraeus Kulzer, Inc. (1); Bd Becton Dickinson Vacutainer Systems Preanalytic (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CFH
- Run a recall and safety report across every CFH manufacturer
- Watch product code CFH 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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