STAT PROFILE PHOX ANALYZER
FDA 510(k) clearance K014295 · decided 2002-02-28
Clearance details
- K-number
- K014295
- Device name
- STAT PROFILE PHOX ANALYZER
- Applicant
- Nova Biomedical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-12-28
- Decision date
- 2002-02-28
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- CHL
- Device class
- 2
- Regulation number
- 862.1120
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Walham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.