The following data is part of a premarket notification filed by Sebia with the FDA for Hydragel 18 A1at Isofocusing Kit (pn 4356).
| Device ID | K063498 |
| 510k Number | K063498 |
| Device Name: | HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356) |
| Classification | Alpha-1-antitrypsin Kit, Qualitative Phenotype |
| Applicant | SEBIA 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11001 |
| Contact | Karen Anderson |
| Correspondent | Karen Anderson SEBIA 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11001 |
| Product Code | OBZ |
| CFR Regulation Number | 866.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-20 |
| Decision Date | 2007-06-11 |
| Summary: | summary |