Product code JLB— Clinical Chemistry
OLYMPUS CK-MB REAGENT
- Classification name
- Atp And Creatine Kinase (Enzymatic), Creatine
- Device class
- Class 1
- Regulation
- 21 CFR 862.1210
- Advisory panel
- Clinical Chemistry
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code JLB
FDA has cleared devices under product code JLB between 1979 and 1999, 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
- 1999
- 1997
- 1979
Top applicants under product code JLB
Recent clearances under product code JLB
Data sourced from openFDA. This site is unofficial and independent of the FDA.