FDA Product Code
FDA Product Code GLY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7500
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K050014 | HEMONIR TM | Nir Diagnostics, Inc. | 2005-05-05 | Traditional | PDF ↗ |
| K993104 | STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR | Nova Biomedical Corp. | 1999-12-02 | Traditional | PDF ↗ |
| K955013 | NOVA CO-OXIMETER ANALYZER | Nova Biomedical Corp. | 1996-04-25 | Traditional | PDF ↗ |
| K952725 | MULTICHECK | Radiometer America, Inc. | 1996-02-20 | Traditional | PDF ↗ |
| K895466 | AVL MODEL 912 CO-OXYLITE | Avl Scientific Corp. | 1989-11-06 | Traditional | PDF ↗ |
Product code GLY · Class II · Hematology. Data: openFDA.