The following data is part of a premarket notification filed by Phadia Us Inc. with the FDA for Elia(tm) Cardiolipin Iga Immunoassay.
| Device ID | K131821 |
| 510k Number | K131821 |
| Device Name: | ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY |
| Classification | System, Test, Anticardiolipin Immunological |
| Applicant | PHADIA US INC. 4169 COMMERCIAL AVE. Portage, MI 49002 |
| Contact | Martin R Mann |
| Correspondent | Martin R Mann PHADIA US INC. 4169 COMMERCIAL AVE. Portage, MI 49002 |
| Product Code | MID |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-20 |
| Decision Date | 2013-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066010755 | K131821 | 000 |
| 07333066013916 | K131821 | 000 |
| 07333066013862 | K131821 | 000 |