The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Autoloader, And Nova View With Models: Aldr1000, And Nv2000.
| Device ID | K153150 |
| 510k Number | K153150 |
| Device Name: | AUTOLoader, And NOVA View With Models: ALDR1000, AND NV2000 |
| Classification | Automated Indirect Immunofluorescence Microscope And Software-assisted System For Clinical Use |
| Applicant | Inova Diagnostics, Inc. 9900 Old Grove Road San Diego, CA 92131 |
| Contact | Gabriella Lakos |
| Correspondent | Gabriella Lakos Inova Diagnostics, Inc. 9900 Old Grove Road San Diego, CA 92131 |
| Product Code | PIV |
| CFR Regulation Number | 866.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-02 |
| Decision Date | 2015-11-24 |
| Summary: | summary |