FDA Product Code
FDA Product Code CFH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1440
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K050790 | SPOTCHEM II LDH TEST | Arkray, Inc. | 2005-06-06 | Traditional | PDF ↗ |
| K020484 | CARESIDE LDH | Careside, Inc. | 2002-07-03 | Traditional | PDF ↗ |
| K895138 | CLINISTAT LDH REAGENT TEST | Heraeus Kulzer, Inc. | 1989-10-19 | Traditional | PDF ↗ |
| K894578 | IQ LDH | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-17 | Traditional | PDF ↗ |
| K880630 | LACTATE DEHYDROGENASE (LDH-L) | Tech-Co, Inc. | 1988-03-16 | Traditional | PDF ↗ |
| K860349 | LACTATE DEHYDROGENASE (LDH) REAGENT SET | Sterling Diagnostics, Inc. | 1986-02-28 | Traditional | PDF ↗ |
| K852391 | EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE | Helena Laboratories | 1985-10-01 | Traditional | PDF ↗ |
| K842452 | WAKO LDH CII TEST | Wako Chemicals USA, Inc. | 1984-08-15 | Traditional | PDF ↗ |
| K820768 | COLORIMETRIC LDH REAGENT SET | Biorent Diagnostic, Inc. | 1982-04-14 | Traditional | PDF ↗ |
| K812836 | LDH REAGENT SET | Anco Medical Reagents & Assoc. | 1981-10-09 | Traditional | PDF ↗ |
| K782176 | HYCEL LDH-INT TEST | Hycel, Inc. | 1979-01-26 | Traditional | PDF ↗ |
| K771343 | LDH-INT TEST | Hycel, Inc. | 1977-08-10 | Traditional | PDF ↗ |
| K760009 | COLORIMETRIC DETERMINATION (LDH) | The Dow Chemical Co. | 1976-07-20 | Traditional | PDF ↗ |
Product code CFH · Class II · Clinical Chemistry. Data: openFDA.