The following data is part of a premarket notification filed by Phadia Us Inc. with the FDA for Elia Gliadin Dp Iga Immunoassay And Elia Gliadin Dp Igg Immunoassay, Models 14-5538-01, 14-5539-01.
| Device ID | K093459 |
| 510k Number | K093459 |
| Device Name: | ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01 |
| Classification | Antibodies, Gliadin |
| Applicant | PHADIA US INC. 4169 COMMERCIAL AVE. Portage, MI 49002 |
| Contact | Martin Robert Mann |
| Correspondent | Martin Robert Mann PHADIA US INC. 4169 COMMERCIAL AVE. Portage, MI 49002 |
| Product Code | MST |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-06 |
| Decision Date | 2010-08-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066010847 | K093459 | 000 |
| 07333066010830 | K093459 | 000 |