The following data is part of a premarket notification filed by Phadia Us Inc. with the FDA for Elia B2-glycoprotein I Iga Immunoassay.
| Device ID | K112414 |
| 510k Number | K112414 |
| Device Name: | ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY |
| Classification | System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) |
| 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 | MSV |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-22 |
| Decision Date | 2012-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066010786 | K112414 | 000 |