510(k) K862067
- Device
- STRATUS DIGITOXIN FLUOROMETRIC ENZYME IMMUNOASSAY
- Applicant
- AMERICAN DADE
- 510(k) number
- K862067
- Product code
- LFM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-06-16
- Date received
- 1986-05-30
- Regulation
- 862.3300
- Classification name
- Enzyme Immunoassay, Digitoxin
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- KAREN H DARCY
- Address
- P.O. Box 25101 Santa Ana CA US 92799 92799
FDA Registration Numbers#
- 3010939897
- 3002806944
- 2432235
- 2250051
- 3012963943
- 3004493545
- 9610126
- 8020888
- 1036362
- 1319681
- 3000308930
- 1219913
- 3002642396
- 3010825766
- 2517506
- 1319809
- 3006198300
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LFM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K062024 | DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2006-07-28 |
| K012112 | RANDOX DIGITOXIN | Randox Laboratories, Ltd. | 2002-01-11 |
| K990251 | DGTX FLEX REAGENT CARTRIDGE, MODEL DF36 | Dade Behring, Inc. | 1999-03-31 |
| K970546 | ACS DIGITOXIN | Chiron Diagnostics Corp. | 1997-07-14 |
| K963158 | ABBOTT AXSYM DIGITOXIN (MODIFY) | Abbott Laboratories | 1996-09-10 |
| K954420 | AXSYM DIGITOXIN | Abbott Laboratories | 1995-12-29 |
| K951631 | DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS | Bayer Corp. | 1995-06-09 |
| K943235 | IMMULITE DIGITOXIN | Diagnostic Products Corp. | 1994-10-27 |
| K942610 | KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN) | Eastman Kodak Company | 1994-10-20 |
| K942619 | EMIT 2000 DIGOXIN ASSAY/CALIBRATORS | Syva Co. | 1994-09-20 |
| K915465 | DIGITOXIN FPIA REAGENT SET | Sigma Diagnostics, Inc. | 1992-01-27 |
| K913187 | INNOFLUOR(TM) DIGITOXIN REAGENT SET | Intl. Bioclinical, Inc. | 1991-09-23 |
| K913240 | DIGITOXIN (FPIA) KIT | Tudor Laboratories, Inc. | 1991-09-06 |
| K900013 | MILENIA (TM) DIGITOXIN | Diagnostic Products Corp. | 1990-03-09 |
| K896021 | CEDIA DIGITOXIN ASSAY | Microgenics Corp. | 1989-11-08 |
Legacy Summary#
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FDA Review#
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