CFH
13 FDA 510(k) clearances · Product code
40 daysmedian time to decision
118 days90th percentile
13clearances measured
FDA profile
- Official device name
- Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1440
- Medical specialty
- Clinical Chemistry
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SPOTCHEM II LDH TEST (K050790) | Arkray, Inc. | 2005-06-06 |
| CARESIDE LDH (K020484) | Careside, Inc. | 2002-07-03 |
| CLINISTAT LDH REAGENT TEST (K895138) | Heraeus Kulzer, Inc. | 1989-10-19 |
| IQ LDH (K894578) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-17 |
| LACTATE DEHYDROGENASE (LDH-L) (K880630) | Tech-Co, Inc. | 1988-03-16 |
| LACTATE DEHYDROGENASE (LDH) REAGENT SET (K860349) | Sterling Diagnostics, Inc. | 1986-02-28 |
| EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE (K852391) | Helena Laboratories | 1985-10-01 |
| WAKO LDH CII TEST (K842452) | Wako Chemicals USA, Inc. | 1984-08-15 |
| COLORIMETRIC LDH REAGENT SET (K820768) | Biorent Diagnostic, Inc. | 1982-04-14 |
| LDH REAGENT SET (K812836) | Anco Medical Reagents & Assoc. | 1981-10-09 |
| HYCEL LDH-INT TEST (K782176) | Hycel, Inc. | 1979-01-26 |
| LDH-INT TEST (K771343) | Hycel, Inc. | 1977-08-10 |
| COLORIMETRIC DETERMINATION (LDH) (K760009) | The Dow Chemical Co. | 1976-07-20 |
Track CFH automatically
Every clearance here is in the API, with alerts when new ones post.