Product code JMA— Clinical Chemistry
HELENA BIOSTRIP A
- Classification name
- Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
- Device class
- Class 1
- Regulation
- 21 CFR 862.1095
- Advisory panel
- Clinical Chemistry
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code JMA
FDA has cleared devices under product code JMA between 1983 and 1993, 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
- 1993
- 1983
Top applicants under product code JMA
Recent clearances under product code JMA
Data sourced from openFDA. This site is unofficial and independent of the FDA.