NOVA LITE(TM) ANA PLUS
FDA 510(k) clearance K881339 · decided 1988-04-21
Clearance details
- K-number
- K881339
- Device name
- NOVA LITE(TM) ANA PLUS
- Applicant
- Inova Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-03-29
- Decision date
- 1988-04-21
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- LLL
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.