The following data is part of a premarket notification filed by Phadia Gmbh with the FDA for Elia Scl-70s Immunoassay.
| Device ID | K140493 |
| 510k Number | K140493 |
| Device Name: | ELIA SCL-70S IMMUNOASSAY |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Applicant | PHADIA GMBH 4169 COMMERCIAL AVE Portage, MI 49002 |
| Contact | Martin R Mann |
| Correspondent | Martin R Mann PHADIA GMBH 4169 COMMERCIAL AVE Portage, MI 49002 |
| Product Code | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-27 |
| Decision Date | 2014-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066010892 | K140493 | 000 |