Product code DBJ— Immunology
IIF-APCA TEST KIT
- Classification name
- Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control
- Device class
- Class 2
- Regulation
- 21 CFR 866.5110
- Advisory panel
- Immunology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code DBJ
FDA has cleared devices under product code DBJ between 1979 and 1993, 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
- 1993
- 1979
Top applicants under product code DBJ
Recent clearances under product code DBJ
Data sourced from openFDA. This site is unofficial and independent of the FDA.