The following data is part of a premarket notification filed by Grifols Usa, Llc with the FDA for Gliadin Iga And Gliadin Lga.
| Device ID | K113377 |
| 510k Number | K113377 |
| Device Name: | GLIADIN IGA AND GLIADIN LGA |
| Classification | Antibodies, Gliadin |
| Applicant | GRIFOLS USA, LLC 2410 LILLYVALE AVE. Los Angeles, CA 90032 |
| Contact | Catherine L Wong |
| Correspondent | Catherine L Wong GRIFOLS USA, LLC 2410 LILLYVALE AVE. Los Angeles, CA 90032 |
| Product Code | MST |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-16 |
| Decision Date | 2012-12-14 |
| Summary: | summary |