CFH — Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase Class II
FDA Device Classification
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 | June 6, 2005 |
| K020484 | careside | CARESIDE LDH | July 3, 2002 |
| K895138 | heraeus kulzer | CLINISTAT LDH REAGENT TEST | October 19, 1989 |
| K894578 | bd becton dickinson vacutainer systems preanalytic | IQ LDH | October 17, 1989 |
| K880630 | tech-co | LACTATE DEHYDROGENASE (LDH-L) | March 16, 1988 |
| K860349 | sterling diagnostics | LACTATE DEHYDROGENASE (LDH) REAGENT SET | February 28, 1986 |
| K852391 | helena laboratories | EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE | October 1, 1985 |
| K842452 | wako chemicals usa | WAKO LDH CII TEST | August 15, 1984 |
| K820768 | biorent diagnostic | COLORIMETRIC LDH REAGENT SET | April 14, 1982 |
| K812836 | anco medical reagents and assoc | LDH REAGENT SET | October 9, 1981 |
| K782176 | hycel | HYCEL LDH-INT TEST | January 26, 1979 |
| K771343 | hycel | LDH-INT TEST | August 10, 1977 |
| K760009 | dow chemical | COLORIMETRIC DETERMINATION (LDH) | July 20, 1976 |