NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM
FDA 510(k) clearance K110648 · decided 2011-08-29
Clearance details
- K-number
- K110648
- Device name
- NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM
- Applicant
- Nova Biomedical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2011-03-04
- Decision date
- 2011-08-29
- Days to decision
- 178 days
- Clearance type
- Special
- Product code
- CHL
- Device class
- 2
- Regulation number
- 862.1120
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.