Product code GPP— Microbiology
LATEX-R RICKETTSII
- Classification name
- Antiserum, Rocky Mountain Spotted Fever
- Device class
- Class 1
- Regulation
- 21 CFR 866.3500
- Advisory panel
- Microbiology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code GPP
FDA has cleared device under product code GPP, all in 1985, 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 GPP
Recent clearances under product code GPP
Data sourced from openFDA. This site is unofficial and independent of the FDA.