510(k) DEN140039
- Device
- NOVA View Automated Fluorescense Microscope
- Applicant
- Inova Diagnostics, Inc.
- 510(k) number
- DEN140039
- Product code
- PIV
- Decision
- Unknown (DENG)
- Decision date
- 2015-04-09
- Date received
- 2014-12-15
- Regulation
- 866.4750
- Classification name
- Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- GABRIELLA LAKOS
- Address
- 9900 Old Grove Rd. San Diego CA US 92131 92131
FDA Registration Numbers#
- 2026994
- 3012348571
- 3007118747
- 3003268355
- 3003825930
- 2918768
- 3004973408
- 3026753391
- 2242436
- 3007361513
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PIV#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K153150 | AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000 | Inova Diagnostics, Inc. | 2015-11-24 |