FERRITIN CONTROL - LEVEL 1, 2, 3
FDA 510(k) clearance K946266 · decided 1995-02-10
Clearance details
- K-number
- K946266
- Device name
- FERRITIN CONTROL - LEVEL 1, 2, 3
- Applicant
- Clinical Controls, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-12-23
- Decision date
- 1995-02-10
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- DGD
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Grover Beach, CA, 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 |
|---|---|---|
| IMX FERRITIN (K881345) | Abbott Laboratories | 1988-05-11 |
| ROENTGENOGRAPHY SET (K830229) | Mallinckrodt Critical Care | 1983-03-09 |
Recalls involving this device
No recalls on record reference this clearance.