The following data is part of a premarket notification filed by Grifols Usa, Inc. with the FDA for Eu-ttg Iga And Eu-ttg Igg.
| Device ID | K102964 |
| 510k Number | K102964 |
| Device Name: | EU-TTG IGA AND EU-TTG IGG |
| Classification | Autoantibodies, Endomysial(tissue Transglutaminase) |
| Applicant | GRIFOLS USA, INC. 2410 LILLYVALE AVENUE Los Angeles, CA 90032 |
| Contact | Catherine L Wong |
| Correspondent | Catherine L Wong GRIFOLS USA, INC. 2410 LILLYVALE AVENUE Los Angeles, CA 90032 |
| Product Code | MVM |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-05 |
| Decision Date | 2011-03-07 |
| Summary: | summary |