IMX FOLATE
FDA 510(k) clearance K943691 · decided 1995-03-23
Clearance details
- K-number
- K943691
- Device name
- IMX FOLATE
- Applicant
- Abbott Mfg., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-07-29
- Decision date
- 1995-03-23
- Days to decision
- 237 days
- Clearance type
- Traditional
- Product code
- CGN
- Device class
- 2
- Regulation number
- 862.1295
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Abbott Park, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Folate Low and High Controls, list 9C13-10; the pack contains 8 - 2 mL bottles( 4 for each recall (Z-0368-04) | Abbott Laboratories HPD/ADD/GPRD | 2004-07-20 |
| IMx Folate Medium Control, list 2220-11; the pack contains 8 - 1 mL bottles of IMx Folate recall (Z-0369-04) | Abbott Laboratories HPD/ADD/GPRD | 2004-07-20 |
| IMx Folate Mode 1 Calibrator Pack, list 2220-40, the pack contains 3 - 2 mL bottles of IMx recall (Z-0370-04) | Abbott Laboratories HPD/ADD/GPRD | 2004-07-20 |
| IMx Specimen Diluent Pack, list 2220-50; 1 - 10 mL bottle containing TRIS buffer with huma recall (Z-0371-04) | Abbott Laboratories HPD/ADD/GPRD | 2004-07-20 |
| IMx Folate Ion Capture Component Set, list 2220-88; the set consists of 1 IMx Folate Reage recall (Z-0372-04) | Abbott Laboratories HPD/ADD/GPRD | 2004-07-20 |