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 |