Product code CZK— Immunology
IL TEST IGG IGA & IGM KITS
- Classification name
- Iga, Rhodamine, Antigen, Antiserum, Control
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code CZK
FDA has cleared device under product code CZK, all in 1984, 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.
Top applicants under product code CZK
Recent clearances under product code CZK
Data sourced from openFDA. This site is unofficial and independent of the FDA.