IMX CA 125
FDA 510(k) clearance K964185 · decided 1997-11-04
Clearance details
- K-number
- K964185
- Device name
- IMX CA 125
- Applicant
- Abbott Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1996-10-21
- Decision date
- 1997-11-04
- Days to decision
- 379 days
- Clearance type
- Traditional
- Product code
- LTK
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Abbott Park, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AxSYM CA 125 Reagent Pack, list 3B41-22 and IMx CA 125 Reagent Pack, list 7A89-22; 100 tes recall (Z-0318-04) | Abbott Laboratories HPD/ADD/GPRD | 2004-01-10 |
| IMx CA 125 Mode 1 Calibrator, list 7A89-40; Abbott Laboratories, Abbott Park, IL 60064 recall (Z-0319-04) | Abbott Laboratories HPD/ADD/GPRD | 2004-01-10 |
| CA 125 Calibrators, list 9C22-01; Abbott Laboratories, Abbott Park, IL 60064 recall (Z-0320-04) | Abbott Laboratories HPD/ADD/GPRD | 2004-01-10 |
| CA 125 Controls, list 9C22-10; Abbott Laboratories, Abbott Park, IL 60064 recall (Z-0322-04) | Abbott Laboratories HPD/ADD/GPRD | 2004-01-10 |