The following data is part of a premarket notification filed by Biokit S.a. with the FDA for Quantia A1-at.
| Device ID | K050596 |
| 510k Number | K050596 |
| Device Name: | QUANTIA A1-AT |
| Classification | Alpha-1-antitrypsin, Antigen, Antiserum, Control |
| Applicant | BIOKIT S.A. LLISSA D'AMUNT Barcelona, ES 08186 |
| Contact | Joan Guixer |
| Correspondent | Joan Guixer BIOKIT S.A. LLISSA D'AMUNT Barcelona, ES 08186 |
| Product Code | DEM |
| Subsequent Product Code | JJS |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-08 |
| Decision Date | 2005-05-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740153519 | K050596 | 000 |
| 00380740054151 | K050596 | 000 |
| 00380740044862 | K050596 | 000 |
| 00380740030131 | K050596 | 000 |
| 00380740156411 | K050596 | 000 |
| 00380740156374 | K050596 | 000 |
| 00380740156299 | K050596 | 000 |