CFH — Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase Class II
FDA product code CFH covers "Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase", a Class II medical device regulated under 21 CFR 862.1440. Submissions are reviewed by the Clinical Chemistry panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CFH
- Device Class
- Class II
- Regulation Number
- 862.1440
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K050790 | Arkray | SPOTCHEM II LDH TEST | Jun 6, 2005 |
| K020484 | Careside | CARESIDE LDH | Jul 3, 2002 |
| K895138 | Heraeus Kulzer | CLINISTAT LDH REAGENT TEST | Oct 19, 1989 |
| K894578 | Bd Becton Dickinson Vacutainer Systems Preanalytic | IQ LDH | Oct 17, 1989 |
| K880630 | Tech-Co | LACTATE DEHYDROGENASE (LDH-L) | Mar 16, 1988 |
| K860349 | Sterling Diagnostics | LACTATE DEHYDROGENASE (LDH) REAGENT SET | Feb 28, 1986 |
| K852391 | Helena Laboratories | EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE | Oct 1, 1985 |
| K842452 | Wako Chemicals Usa | WAKO LDH CII TEST | Aug 15, 1984 |
| K820768 | Biorent Diagnostic | COLORIMETRIC LDH REAGENT SET | Apr 14, 1982 |
| K812836 | Anco Medical Reagents And Assoc | LDH REAGENT SET | Oct 9, 1981 |
| K782176 | Hycel | HYCEL LDH-INT TEST | Jan 26, 1979 |
| K771343 | Hycel | LDH-INT TEST | Aug 10, 1977 |
| K760009 | Dow Chemical | COLORIMETRIC DETERMINATION (LDH) | Jul 20, 1976 |