Product code JWK— Microbiology
CRYPTOCOCCUS NEOFORMANS, ANTIGEN,
- Classification name
- Antigen, Positive Control, Cryptococcus Neoformans
- Device class
- Class 2
- Regulation
- 21 CFR 866.3165
- Advisory panel
- Microbiology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code JWK
FDA has cleared device under product code JWK, all in 1980, 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 JWK
Recent clearances under product code JWK
Data sourced from openFDA. This site is unofficial and independent of the FDA.