Product code CKC— Clinical Chemistry
SERAYZER ALT/SGPT REAGENT STRIPS
- Classification name
- Vanillin Pyruvate, Alt/Sgpt
- Device class
- Class 1
- Regulation
- 21 CFR 862.1030
- Advisory panel
- Clinical Chemistry
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code CKC
FDA has cleared devices under product code CKC between 1978 and 1983, filed by 2 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
- 1983
- 1978
Top applicants under product code CKC
Recent clearances under product code CKC
Data sourced from openFDA. This site is unofficial and independent of the FDA.