K190088 is an FDA 510(k) clearance for the QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents. This device is classified as a System, Test, Rheumatoid Factor (Class II - Special Controls, product code DHR).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on April 17, 2019, 90 days after receiving the submission on January 17, 2019.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5775.
| 510(k) Number | K190088 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 17, 2019 |
| Decision Date | April 17, 2019 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DHR — System, Test, Rheumatoid Factor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5775 |