Product code IBM— Pathology
HEMAVIEW DARKFIELD MICROSCOPE SYSTEM
- Classification name
- Microscope, Phase Contrast
- Device class
- Class 1
- Regulation
- 21 CFR 864.3600
- Advisory panel
- Pathology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code IBM
FDA has cleared device under product code IBM, all in 1989, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Top applicants under product code IBM
Recent clearances under product code IBM
Data sourced from openFDA. This site is unofficial and independent of the FDA.