The following data is part of a premarket notification filed by Sebia with the FDA for Capillarys Urine.
| Device ID | K080916 |
| 510k Number | K080916 |
| Device Name: | CAPILLARYS URINE |
| Classification | Immunochemical, Bence-jones Protein |
| Applicant | SEBIA 400-1705 CORPORATE DRIVE SUITE 400 Norcross, GA 30093 |
| Contact | Karen Anderson |
| Correspondent | Karen Anderson SEBIA 400-1705 CORPORATE DRIVE SUITE 400 Norcross, GA 30093 |
| Product Code | JKM |
| CFR Regulation Number | 866.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-02 |
| Decision Date | 2008-07-01 |