Product code GGZ— Hematology
Stat Profile Prime Plus Analyzer System
- Classification name
- Oxyhemoglobin
- Device class
- Class 2
- Regulation
- 21 CFR 864.7500
- Advisory panel
- Hematology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code GGZ
FDA has cleared devices under product code GGZ between 2018 and 2020, filed by 1 applicant company. 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
- 2020
- 2018
Top applicants under product code GGZ
Recent clearances under product code GGZ
Data sourced from openFDA. This site is unofficial and independent of the FDA.