The following data is part of a premarket notification filed by Biokit S.a. with the FDA for Quantia Ige.
| Device ID | K050493 |
| 510k Number | K050493 |
| Device Name: | QUANTIA IGE |
| Classification | Ige, Antigen, Antiserum, Control |
| Applicant | BIOKIT S.A. CAN MALE LLISSA D'AMUNT Barcelona, ES 08186 |
| Contact | Joan Guixer |
| Correspondent | Joan Guixer BIOKIT S.A. CAN MALE LLISSA D'AMUNT Barcelona, ES 08186 |
| Product Code | DGC |
| Subsequent Product Code | JJS |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-28 |
| Decision Date | 2005-08-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740054243 | K050493 | 000 |
| 00380740044848 | K050493 | 000 |
| 00380740030100 | K050493 | 000 |
| 00380740156404 | K050493 | 000 |
| 00380740156367 | K050493 | 000 |
| 00380740156282 | K050493 | 000 |