Product code GTP— Microbiology
LEAP STREP TEST KIT
- Classification name
- Exoenzymes, Multiple, Streptococcal
- Device class
- Class 1
- Regulation
- 21 CFR 866.3720
- Advisory panel
- Microbiology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code GTP
FDA has cleared devices under product code GTP between 1982 and 1986, filed by 3 applicant companies. 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.
Clearances per year
- 1986
- 1983
- 1982
Top applicants under product code GTP
Recent clearances under product code GTP
Data sourced from openFDA. This site is unofficial and independent of the FDA.