K191635 is an FDA 510(k) clearance for the Optilite IgM Kit. This device is classified as a Method, Nephelometric, Immunoglobulins (g, A, M) (Class II - Special Controls, product code CFN).
Submitted by The Binding Site Group , Ltd. (Edgbaston, GB). The FDA issued a Cleared decision on July 15, 2019, 26 days after receiving the submission on June 19, 2019.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K191635 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 2019 |
| Decision Date | July 15, 2019 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | CFN — Method, Nephelometric, Immunoglobulins (g, A, M) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |