Product code JBY— Hematology
LUMI-AGGREGOMETER
- Classification name
- Aggregometer, Platelet, Photo-Optical Scanning
- Device class
- Class 2
- Regulation
- 21 CFR 864.6675
- Advisory panel
- Hematology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code JBY
FDA has cleared devices under product code JBY between 1977 and 1991, 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
- 1991
- 1977
Top applicants under product code JBY
Recent clearances under product code JBY
Data sourced from openFDA. This site is unofficial and independent of the FDA.