Product code JFR— Immunology
CERULOPLASMIN FOR THE TECHNICON DPA-1(TM) SYSTEM
- Classification name
- Indirect Copper Assay, Ceruloplasmin
- Device class
- Class 2
- Regulation
- 21 CFR 866.5210
- Advisory panel
- Immunology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code JFR
FDA has cleared devices under product code JFR between 1988 and 2005, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2005
- 1988
Top applicants under product code JFR
Recent clearances under product code JFR
Data sourced from openFDA. This site is unofficial and independent of the FDA.