IMMULITE DIGITOXIN
FDA 510(k) clearance K943235 · decided 1994-10-27
Clearance details
- K-number
- K943235
- Device name
- IMMULITE DIGITOXIN
- Applicant
- Diagnostic Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 1994-07-06
- Decision date
- 1994-10-27
- Days to decision
- 113 days
- Clearance type
- Traditional
- Product code
- LFM
- Device class
- 2
- Regulation number
- 862.3300
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Diagnostic Products Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE (K062024) | Dade Behring, Inc. | 2006-07-28 |
| RANDOX DIGITOXIN (K012112) | Randox Laboratories, Ltd. | 2002-01-11 |
| DGTX FLEX REAGENT CARTRIDGE, MODEL DF36 (K990251) | Dade Behring, Inc. | 1999-03-31 |
| ACS DIGITOXIN (K970546) | Chiron Diagnostics Corp. | 1997-07-14 |
| ABBOTT AXSYM DIGITOXIN (MODIFY) (K963158) | Abbott Laboratories | 1996-09-10 |
| AXSYM DIGITOXIN (K954420) | Abbott Laboratories | 1995-12-29 |
| DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS (K951631) | Bayer Corp. | 1995-06-09 |
| KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN) (K942610) | Eastman Kodak Company | 1994-10-20 |
| EMIT 2000 DIGOXIN ASSAY/CALIBRATORS (K942619) | Syva Co. | 1994-09-20 |
| DIGITOXIN FPIA REAGENT SET (K915465) | Sigma Diagnostics, Inc. | 1992-01-27 |
| INNOFLUOR(TM) DIGITOXIN REAGENT SET (K913187) | Intl. Bioclinical, Inc. | 1991-09-23 |
| DIGITOXIN (FPIA) KIT (K913240) | Tudor Laboratories, Inc. | 1991-09-06 |
Recalls involving this device
No recalls on record reference this clearance.