Product code DEY— Immunology
AEC DETECTION KIT
- Classification name
- Igm, Peroxidase, Antigen, Antiserum, Control
- Device class
- Class 2
- Regulation
- 21 CFR 866.5550
- Advisory panel
- Immunology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code DEY
FDA has cleared devices under product code DEY between 1992 and 1993, filed by 1 applicant company. 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
- 1992
Top applicants under product code DEY
Recent clearances under product code DEY
Data sourced from openFDA. This site is unofficial and independent of the FDA.