NOVA 13 ANALYZER
FDA 510(k) clearance K912561 · decided 1991-09-11
Clearance details
- K-number
- K912561
- Device name
- NOVA 13 ANALYZER
- Applicant
- Nova Biomedical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-06-11
- Decision date
- 1991-09-11
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- CGZ
- Device class
- 2
- Regulation number
- 862.1170
- 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.