LFM — Enzyme Immunoassay, Digitoxin Class II
FDA product code LFM covers "Enzyme Immunoassay, Digitoxin", a Class II medical device regulated under 21 CFR 862.3300. Submissions are reviewed by the Clinical Toxicology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LFM
- Device Class
- Class II
- Regulation Number
- 862.3300
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K062024 | dade behring | DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, | July 28, 2006 |
| K012112 | randox laboratories | RANDOX DIGITOXIN | January 11, 2002 |
| K990251 | dade behring | DGTX FLEX REAGENT CARTRIDGE, MODEL DF36 | March 31, 1999 |
| K970546 | chiron diagnostics | ACS DIGITOXIN | July 14, 1997 |
| K963158 | abbott laboratories | ABBOTT AXSYM DIGITOXIN (MODIFY) | September 10, 1996 |
| K954420 | abbott laboratories | AXSYM DIGITOXIN | December 29, 1995 |
| K951631 | bayer | DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS | June 9, 1995 |
| K943235 | diagnostic products | IMMULITE DIGITOXIN | October 27, 1994 |
| K942610 | eastman kodak | KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN) | October 20, 1994 |
| K942619 | syva | EMIT 2000 DIGOXIN ASSAY/CALIBRATORS | September 20, 1994 |
| K915465 | sigma diagnostics | DIGITOXIN FPIA REAGENT SET | January 27, 1992 |
| K913187 | intl. bioclinical | INNOFLUOR(TM) DIGITOXIN REAGENT SET | September 23, 1991 |
| K913240 | tudor laboratories | DIGITOXIN (FPIA) KIT | September 6, 1991 |
| K900013 | diagnostic products | MILENIA (TM) DIGITOXIN | March 9, 1990 |
| K896021 | microgenics | CEDIA DIGITOXIN ASSAY | November 8, 1989 |
| K891094 | e.i. dupont de nemours and co | ACA(R) DIGITOXIN (DGTX) METHOD | April 26, 1989 |
| K862067 | american dade | STRATUS DIGITOXIN FLUOROMETRIC ENZYME IMMUNOASSAY | June 16, 1986 |
| K842280 | abbott laboratories | TDX DIGITOXIN | August 16, 1984 |
| K842578 | diagnostic products | SOPHEIA/MP DIGITOXIN EIA KIT | August 12, 1984 |
| K830035 | diagnostic products | SOPHEIA DIGITOXIN EIA KIT & COMPONENTS | January 28, 1983 |