GLY · Oximeter To Measure Hemoglobin
Hematology · 21 CFR 864.7500 · Class 2
Overview
| Product Code | GLY |
|---|---|
| Device Name | Oximeter To Measure Hemoglobin |
| Regulation | 21 CFR 864.7500 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems.
Classification Rationale
Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Special Controls
*Classification.* Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K050014 | HEMONIR TM | Nir Diagnostics, Inc. | May 5, 2005 | SESE |
| K993104 | STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR | Nova Biomedical Corp. | Dec 2, 1999 | SESE |
| K955013 | NOVA CO-OXIMETER ANALYZER | Nova Biomedical Corp. | Apr 25, 1996 | SESE |
| K952725 | MULTICHECK | Radiometer America, Inc. | Feb 20, 1996 | SESE |
| K895466 | AVL MODEL 912 CO-OXYLITE | Avl Scientific Corp. | Nov 6, 1989 | SESE |
Top Applicants
- Nova Biomedical Corp. — 2 clearances
- Radiometer America, Inc. — 1 clearance
- Nir Diagnostics, Inc. — 1 clearance
- Avl Scientific Corp. — 1 clearance
