The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Flash Hmgcr Reagents.
| Device ID | K180975 |
| 510k Number | K180975 |
| Device Name: | QUANTA Flash HMGCR Reagents |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | Inova Diagnostics, Inc. 9900 Old Grove Rd. San Diego, CA 92131 -1638 |
| Contact | Roger Albesa |
| Correspondent | Roger Albesa Inova Diagnostics, Inc. 9900 Old Grove Rd. San Diego, CA 92131 -1638 |
| Product Code | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-13 |
| Decision Date | 2018-06-25 |
| Summary: | summary |