Product code JBL— Hematology
ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K
- Classification name
- Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative
- Device class
- Class 2
- Regulation
- 21 CFR 864.7360
- Advisory panel
- Hematology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code JBL
FDA has cleared devices under product code JBL between 1979 and 1999, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1999
- 1979
Top applicants under product code JBL
Recent clearances under product code JBL
Data sourced from openFDA. This site is unofficial and independent of the FDA.