The following data is part of a premarket notification filed by Sebia with the FDA for Flc Kappa, Flc Lambda, Flc Control Level 1, Flc Control Level 2.
| Device ID | K210623 |
| 510k Number | K210623 |
| Device Name: | FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 |
| Classification | Kappa, Antigen, Antiserum, Control |
| Applicant | Sebia 1705 Corporate Drive Suite 400 Norcross, GA 30093 |
| Contact | Karen Anderson |
| Correspondent | Karen Anderson Sebia 1705 Corporate Drive Suite 400 Norcross, GA 30093 |
| Product Code | DFH |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-02 |
| Decision Date | 2022-11-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03607360051030 | K210623 | 000 |
| 03607360051023 | K210623 | 000 |