FDA 510(k) Applications for Medical Device Product Code "LFM"
(Enzyme Immunoassay, Digitoxin)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K963158 | ABBOTT LABORATORIES | ABBOTT AXSYM DIGITOXIN (MODIFY) | 09/10/1996 |
| K970546 | CHIRON DIAGNOSTICS CORP. | ACS DIGITOXIN | 07/14/1997 |
| K990251 | DADE BEHRING, INC. | DGTX FLEX REAGENT CARTRIDGE, MODEL DF36 | 03/31/1999 |
| K062024 | DADE BEHRING, INC. | DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE | 07/28/2006 |
| K012112 | RANDOX LABORATORIES, LTD. | RANDOX DIGITOXIN | 01/11/2002 |
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