The following data is part of a premarket notification filed by Sweden Diagnostics (germany) Gmbh with the FDA for Varelisa Recombi Ctd Screen, Model 13096.
| Device ID | K050967 |
| 510k Number | K050967 |
| Device Name: | VARELISA RECOMBI CTD SCREEN, MODEL 13096 |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Applicant | SWEDEN DIAGNOSTICS (GERMANY) GMBH MUNZINGER STRASSE 7 Freiburg, DE D-79111 |
| Contact | Michael Linss |
| Correspondent | Michael Linss SWEDEN DIAGNOSTICS (GERMANY) GMBH MUNZINGER STRASSE 7 Freiburg, DE D-79111 |
| Product Code | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-18 |
| Decision Date | 2005-06-28 |
| Summary: | summary |