The following data is part of a premarket notification filed by Phadia Us Inc. with the FDA for Elia Dsdna Immunoassay, Model 14-5500-01, Elia Ana Control, Model 83-1004-01.
| Device ID | K072393 |
| 510k Number | K072393 |
| Device Name: | ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01 |
| Classification | Anti-dna Antibody, Antigen And 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 | LSW |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-27 |
| Decision Date | 2007-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066010557 | K072393 | 000 |
| 07333066013879 | K072393 | 000 |
| 07333066013824 | K072393 | 000 |