NOVA View Automated Fluorescense Microscope
FDA 510(k) clearance DEN140039 · decided 2015-04-09
Clearance details
- K-number
- DEN140039
- Device name
- NOVA View Automated Fluorescense Microscope
- Applicant
- Inova Diagnostics, Inc.
- Decision
- Unknown
- Date received
- 2014-12-15
- Decision date
- 2015-04-09
- Days to decision
- 115 days
- Clearance type
- Post-NSE
- Product code
- PIV
- Device class
- 2
- Regulation number
- 866.4750
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- San Diego, CA, 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 |
|---|---|---|
| AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000 (K153150) | Inova Diagnostics, Inc. | 2015-11-24 |
Recalls involving this device
No recalls on record reference this clearance.