Panels › Clinical Toxicology › Product code LFM · Class 2
Enzyme Immunoassay, Digitoxin
Regulation 862.3300
0510(k)s in 12 months (20 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in LFM
| Company | 510(k)s | Recalls |
|---|---|---|
| Diagnostic Products Corp. | 4 | 0 |
| Abbott Laboratories | 3 | 0 |
| Dade Behring, Inc. | 2 | 0 |
| Ortho-Clinical Diagnostics | 0 | 2 |
| QUIDEL ORTHO | 0 | 2 |
| American Dade | 1 | 0 |
| Bayer Corp. | 1 | 0 |
| Chiron Diagnostics Corp. | 1 | 0 |
| E.I. Dupont DE Nemours & Co., Inc. | 1 | 0 |
| Eastman Kodak Company | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 28, 2006 | K062024 | DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE Dade Behring, Inc. | LFM |
| Jan 11, 2002 | K012112 | RANDOX DIGITOXIN Randox Laboratories, Ltd., GB | LFM |
| Mar 31, 1999 | K990251 | DGTX FLEX REAGENT CARTRIDGE, MODEL DF36 Dade Behring, Inc. | LFM |
| Jul 14, 1997 | K970546 | ACS DIGITOXIN Chiron Diagnostics Corp. | LFM |
| Sep 10, 1996 | K963158 | ABBOTT AXSYM DIGITOXIN (MODIFY) Abbott Laboratories | LFM |
| Dec 29, 1995 | K954420 | AXSYM DIGITOXIN Abbott Laboratories | LFM |
| Jun 9, 1995 | K951631 | DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS Bayer Corp. | LFM |
| Oct 27, 1994 | K943235 | IMMULITE DIGITOXIN Diagnostic Products Corp. | LFM |
| Oct 20, 1994 | K942610 | KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN) Eastman Kodak Company | LFM |
| Sep 20, 1994 | K942619 | EMIT 2000 DIGOXIN ASSAY/CALIBRATORS Syva Co. | LFM |
| Jan 27, 1992 | K915465 | DIGITOXIN FPIA REAGENT SET Sigma Diagnostics, Inc. | LFM |
| Sep 23, 1991 | K913187 | INNOFLUOR(TM) DIGITOXIN REAGENT SET Intl. Bioclinical, Inc. | LFM |
| Sep 6, 1991 | K913240 | DIGITOXIN (FPIA) KIT Tudor Laboratories, Inc. | LFM |
| Mar 9, 1990 | K900013 | MILENIA (TM) DIGITOXIN Diagnostic Products Corp. | LFM |
| Nov 8, 1989 | K896021 | CEDIA DIGITOXIN ASSAY Microgenics Corp. | LFM |
| Apr 26, 1989 | K891094 | ACA(R) DIGITOXIN (DGTX) METHOD E.I. Dupont DE Nemours & Co., Inc. | LFM |
| Jun 16, 1986 | K862067 | STRATUS DIGITOXIN FLUOROMETRIC ENZYME IMMUNOASSAY American Dade | LFM |
| Aug 16, 1984 | K842280 | TDX DIGITOXIN Abbott Laboratories | LFM |
| Aug 12, 1984 | K842578 | SOPHEIA/MP DIGITOXIN EIA KIT Diagnostic Products Corp. | LFM |
| Jan 28, 1983 | K830035 | SOPHEIA DIGITOXIN EIA KIT & COMPONENTS Diagnostic Products Corp. | LFM |
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