Sentinel Ceruloplasmin
FDA 510(k) K051456 · Sentinel Ch. Srl
510(k) numberK051456
Submission
- Device name
- Sentinel Ceruloplasmin
- Applicant
- Sentinel Ch. Srl
Milano, IT - Received
- June 2, 2005
- Decision date
- October 21, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JFR – Indirect Copper Assay, Ceruloplasmin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5210
- Specialty
- Immunology
Other 510(k)s with product code JFR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K882622 | Ceruloplasmin for the Technicon DPA-1(TM) SystemJFR · Traditional | Technicon Instruments Corp. | 07/08/1988SE |
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Questions and answers
When was Sentinel Ceruloplasmin cleared by the FDA?
Sentinel Ceruloplasmin (K051456) received a 510(k) decision of Substantially Equivalent on October 21, 2005, 141 days after the submission was received.
What is the product code of K051456?
The FDA product code is JFR – Indirect Copper Assay, Ceruloplasmin, a Class II (moderate risk) device regulated under 21 CFR 866.5210.