510(k) K051456
- Device
- SENTINEL CERULOPLASMIN
- Applicant
- SENTINEL CH. SRL
- 510(k) number
- K051456
- Product code
- JFR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-10-21
- Date received
- 2005-06-02
- Regulation
- 866.5210
- Classification name
- Indirect Copper Assay, Ceruloplasmin
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVIDE SPADA
- Address
- 5 Via Principe Eugenio Milano IT 20155 20155
FDA Registration Numbers#
- 3003741796
- 3002809144
- 9681753
- 3005333358
Source Documents#
Other 510(k) Records For Product Code JFR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K882622 | CERULOPLASMIN FOR THE TECHNICON DPA-1(TM) SYSTEM | Technicon Instruments Corp. | 1988-07-08 |
Legacy Summary#
summary
FDA Review#
Decision Summary