510(k) K153150
- Device
- AUTOLoader, And NOVA View With Models: ALDR1000, AND NV2000
- Applicant
- Inova Diagnostics, Inc.
- 510(k) number
- K153150
- Product code
- PIV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-11-24
- Date received
- 2015-11-02
- 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
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Gabriella Lakos
- Address
- 9900 Old Grove Rd. San Diego CA US 92131 92131
FDA Registration Numbers#
- 2918768
- 2026994
- 3007361513
- 3003268355
- 2242436
- 3004973408
- 3026753391
- 3003825930
- 3007118747
Source Documents#
Other 510(k) Records For Product Code PIV #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN140039 | NOVA View Automated Fluorescense Microscope | Inova Diagnostics, Inc. | 2015-04-09 |
Legacy Summary#
summary
FDA Review#
Decision Summary