Product code LRF— Microbiology
CANDIDATE(R) SUPER
- Classification name
- Candida Spp., Direct Antigen, Id
- Device class
- Class 2
- Regulation
- 21 CFR 866.3165
- Advisory panel
- Microbiology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code LRF
FDA has cleared devices under product code LRF between 1984 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
- 1987
- 1984
Top applicants under product code LRF
Recent clearances under product code LRF
Data sourced from openFDA. This site is unofficial and independent of the FDA.