ABBOTT AXSYM DIGITOXIN (MODIFY)
FDA 510(k) clearance K963158 · decided 1996-09-10
Clearance details
- K-number
- K963158
- Device name
- ABBOTT AXSYM DIGITOXIN (MODIFY)
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1996-07-26
- Decision date
- 1996-09-10
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- LFM
- Device class
- 2
- Regulation number
- 862.3300
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Abbott Park, IL, US
- Third-party review
- No
- Expedited review
- No
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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 |
| 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 |
| IMMULITE DIGITOXIN (K943235) | Diagnostic Products Corp. | 1994-10-27 |
| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT AFP / Alinity i AFP (P120008/S030) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012) | Abbott Laboratories | 2024-09-30 |