AXSYM CK-MB
FDA 510(k) clearance K935924 · decided 1994-06-21
Clearance details
- K-number
- K935924
- Device name
- AXSYM CK-MB
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1993-12-13
- Decision date
- 1994-06-21
- Days to decision
- 190 days
- Clearance type
- Traditional
- Product code
- JHW
- Device class
- 2
- Regulation number
- 862.1215
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Abbott Park, IL, US
- Third-party review
- No
- Expedited review
- No
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| ROCHE DIAGNOSTICS CK-MB (K003158) | Roche Diagnostics Corp. | 2000-12-18 |
| ELECSYS CK-MB (K961501) | Boehringer Mannheim Corp. | 1996-06-11 |
| CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM (K950186) | Miles, Inc. | 1995-03-13 |
| LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN (K944325) | Princeton BioMeditech Corp. | 1995-02-22 |
| CREATINE KINASE MB DETERMINATION (UV) (K942958) | Biochemical Trade, Inc. | 1994-11-21 |
| CARDIO REP CK ISOENZYME KIT - 3310 (K931050) | Helena Laboratories | 1993-04-20 |
| STAMBI-CK (K913349) | Intl. Immunoassay Laboratories, Inc. | 1991-10-23 |
| PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT (K912231) | Intl. Immunoassay Laboratories, Inc. | 1991-07-08 |
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 |