GLY
5 FDA 510(k) clearances · Product code
122 daysmedian time to decision
251 days90th percentile
5clearances measured
FDA profile
- Official device name
- Oximeter To Measure Hemoglobin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7500
- Medical specialty
- Hematology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| HEMONIR TM (K050014) | Nir Diagnostics, Inc. | 2005-05-05 |
| STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR (K993104) | Nova Biomedical Corp. | 1999-12-02 |
| NOVA CO-OXIMETER ANALYZER (K955013) | Nova Biomedical Corp. | 1996-04-25 |
| MULTICHECK (K952725) | Radiometer America, Inc. | 1996-02-20 |
| AVL MODEL 912 CO-OXYLITE (K895466) | Avl Scientific Corp. | 1989-11-06 |
Track GLY automatically
Every clearance here is in the API, with alerts when new ones post.