The following data is part of a premarket notification filed by Sweden Diagnostics (germany) Gmbh with the FDA for Varelisa Sm Antibodies, Model 18296.
| Device ID | K042629 |
| 510k Number | K042629 |
| Device Name: | VARELISA SM ANTIBODIES, MODEL 18296 |
| Classification | Anti-sm Antibody, Antigen And Control |
| Applicant | SWEDEN DIAGNOSTICS (GERMANY) GMBH MUNZINGER STRASSE 7 Freiburg, DE D-79111 |
| Contact | Sabine Klugbauer |
| Correspondent | Sabine Klugbauer SWEDEN DIAGNOSTICS (GERMANY) GMBH MUNZINGER STRASSE 7 Freiburg, DE D-79111 |
| Product Code | LKP |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-27 |
| Decision Date | 2004-12-08 |
| Summary: | summary |