Panels › Hematology › Product code GLY · Class 2
Oximeter To Measure Hemoglobin
Regulation 864.7500
0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in GLY
| Company | 510(k)s | Recalls |
|---|---|---|
| Nova Biomedical Corp. | 2 | 0 |
| Avl Scientific Corp. | 1 | 0 |
| Nir Diagnostics, Inc. | 1 | 0 |
| Radiometer America, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 5, 2005 | K050014 | HEMONIR TM Nir Diagnostics, Inc. | GLY |
| Dec 2, 1999 | K993104 | STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR Nova Biomedical Corp. | GLY |
| Apr 25, 1996 | K955013 | NOVA CO-OXIMETER ANALYZER Nova Biomedical Corp. | GLY |
| Feb 20, 1996 | K952725 | MULTICHECK Radiometer America, Inc. | GLY |
| Nov 6, 1989 | K895466 | AVL MODEL 912 CO-OXYLITE Avl Scientific Corp. | GLY |
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