The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Flash Rf Igm Reagents, Quanta Flash Rf Iga Reagents.
| Device ID | K190088 |
| 510k Number | K190088 |
| Device Name: | QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents |
| Classification | System, Test, Rheumatoid Factor |
| 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 | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-17 |
| Decision Date | 2019-04-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950845249 | K190088 | 000 |
| 08426950835189 | K190088 | 000 |