The following data is part of a premarket notification filed by Phadia Us Inc. with the FDA for Elia Symphony Immunoassay, Ana Control, Model 14-55508-01,83-1004-01.
| Device ID | K072149 |
| 510k Number | K072149 |
| Device Name: | ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01 |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | PHADIA US INC. 4169 COMMERCIAL AVE. Portage, MI 49002 |
| Contact | Martin Mann |
| Correspondent | Martin Mann PHADIA US INC. 4169 COMMERCIAL AVE. Portage, MI 49002 |
| Product Code | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-03 |
| Decision Date | 2008-01-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066010632 | K072149 | 000 |