The following data is part of a premarket notification filed by The Binding Site Group Ltd. with the FDA for Optilite Igm Csf Kit.
| Device ID | K190686 |
| 510k Number | K190686 |
| Device Name: | Optilite IgM CSF Kit |
| Classification | Method, Nephelometric, Immunoglobulins (g, A, M) |
| Applicant | The Binding Site Group Ltd. 8 Calthorpe Road Edgbaston, GB B15 1qt |
| Contact | Kanika Darbar |
| Correspondent | Kanika Darbar The Binding Site Group Ltd. 8 Calthorpe Road Edgbaston, GB B15 1qt |
| Product Code | CFN |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-18 |
| Decision Date | 2019-05-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700020183 | K190686 | 000 |