Product code DAN— Immunology
ASSERACHROM FPA KIT
- Classification name
- Fibrinopeptide A, Antigen, Antiserum, Control
- Device class
- Class 2
- Regulation
- 21 CFR 866.5350
- Advisory panel
- Immunology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code DAN
FDA has cleared devices under product code DAN between 1982 and 1988, filed by 3 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
- 1988
- 1986
- 1982
Top applicants under product code DAN
Recent clearances under product code DAN
Data sourced from openFDA. This site is unofficial and independent of the FDA.