GGZ · Class II · 21 CFR 864.7500

FDA Product Code GGZ: Oxyhemoglobin

Leading manufacturers include Nova Biomedical Corporation.

2
Total
2
Cleared
141d
Avg days
2018
Since

FDA 510(k) Cleared Oxyhemoglobin Devices (Product Code GGZ)

2 devices
1–2 of 2
Cleared Apr 06, 2020
Stat Profile Prime Plus Analyzer System
K200204
Nova Biomedical Corporation
Chemistry · 69d
Cleared Aug 23, 2018
Stat Profile Prime Plus Analyzer System
K180186
Nova Biomedical Corporation
Chemistry · 212d

About Product Code GGZ - Regulatory Context