AXSYM THEOPHYLLINE II
FDA 510(k) clearance K953016 · decided 1995-08-24
Clearance details
- K-number
- K953016
- Device name
- AXSYM THEOPHYLLINE II
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1995-06-29
- Decision date
- 1995-08-24
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- LGS
- Device class
- 2
- Regulation number
- 862.3880
- 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 |
|---|---|---|
| ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F) (K070810) | Biokit, S.A. | 2007-06-08 |
| INNOFLUOR THEOPHYLLINE ASSAY SYSTEM (K955567) | Oxis Intl., Inc. | 1996-01-24 |
| CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY (K951169) | Ciba Corning Diagnostics Corp. | 1995-06-20 |
| QMS THEOPHYLLINE CS (K942991) | Seradyn, Inc. | 1994-09-09 |
| TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL II (K932127) | Abbott Laboratories | 1993-08-09 |
| ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE (K922991) | Abbott Laboratories | 1992-08-27 |
| MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA (K900706) | Innotron of Oregon, Inc. | 1990-04-12 |
| FPR THEOPHYLLINE KIT (K894529) | Colony Laboratories, Inc. | 1989-09-15 |
| COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS (K871484) | Roche Diagnostic Systems, Inc. | 1987-05-28 |
| MONITORX LASERX THEOPHYLLINE REAGENT SET (K870277) | American Monitor Corp. | 1987-02-18 |
| INNOFLUOR THEOPHYLLINE (K850629) | Innotron Diagnostics | 1985-03-12 |
| COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL (K843826) | Roche Diagnostic Systems, Inc. | 1985-02-01 |
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 |