The following data is part of a premarket notification filed by Phadia Us Inc. with the FDA for Elia Cenp Immunoassay, Elia U1rnp Immunoassay, Elia Sm Immunoassay, Elia Ro Immunoassay.
| Device ID | K082759 |
| 510k Number | K082759 |
| Device Name: | ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY |
| Classification | Antinuclear Antibody, Antigen, Control |
| 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 | LKJ |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-22 |
| Decision Date | 2009-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066010601 | K082759 | 000 |
| 07333066010595 | K082759 | 000 |
| 07333066010588 | K082759 | 000 |
| 07333066010571 | K082759 | 000 |
| 07333066010564 | K082759 | 000 |