Product code GJZ— Hematology
CELL-DYN RAPID-LYSE AND HEMOGLOBLIN
- Classification name
- Cyanomethemoglobin Reagent And Standard Solution
- Device class
- Class 2
- Regulation
- 21 CFR 864.7500
- Advisory panel
- Hematology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code GJZ
FDA has cleared devices under product code GJZ, all in 1988, 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.
Top applicants under product code GJZ
Recent clearances under product code GJZ
Data sourced from openFDA. This site is unofficial and independent of the FDA.