Product code KIW— Hematology
GIBCO MYCOTECT 189-5670
- Classification name
- Kit, Mycoplasma Detection
- Device class
- Class 1
- Regulation
- 21 CFR 864.2360
- Advisory panel
- Hematology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code KIW
FDA has cleared devices under product code KIW between 1985 and 1986, 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.
Clearances per year
- 1986
- 1985
Top applicants under product code KIW
Recent clearances under product code KIW
Data sourced from openFDA. This site is unofficial and independent of the FDA.