SENTINEL CERULOPLASMIN
FDA 510(k) clearance K051456 · decided 2005-10-21
Clearance details
- K-number
- K051456
- Device name
- SENTINEL CERULOPLASMIN
- Applicant
- Sentinel Ch. Srl
- Decision
- Substantially Equivalent
- Date received
- 2005-06-02
- Decision date
- 2005-10-21
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- JFR
- Device class
- 2
- Regulation number
- 866.5210
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Milano, IT
- 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 |
|---|---|---|
| CERULOPLASMIN FOR THE TECHNICON DPA-1(TM) SYSTEM (K882622) | Technicon Instruments Corp. | 1988-07-08 |
Recalls involving this device
No recalls on record reference this clearance.