STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR
FDA 510(k) clearance K993104 · decided 1999-12-02
Clearance details
- K-number
- K993104
- Device name
- STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR
- Applicant
- Nova Biomedical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-09-16
- Decision date
- 1999-12-02
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- GLY
- Device class
- 2
- Regulation number
- 864.7500
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Walham, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HEMONIR TM (K050014) | Nir Diagnostics, Inc. | 2005-05-05 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.