Product code GRY— Microbiology
LEPTOSPIROSIS IHA
- Classification name
- Antigens, All, Leptospira Spp.
- Device class
- Class 2
- Regulation
- 21 CFR 866.3350
- Advisory panel
- Microbiology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code GRY
FDA has cleared devices under product code GRY between 1988 and 2000, filed by 2 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
- 2000
- 1988
Top applicants under product code GRY
Recent clearances under product code GRY
Data sourced from openFDA. This site is unofficial and independent of the FDA.