The following data is part of a premarket notification filed by Pharmacia Deutschland Gmbh with the FDA for Varelisa Pr3 Anca, Model Number 17748/17796.
| Device ID | K041043 |
| 510k Number | K041043 |
| Device Name: | VARELISA PR3 ANCA, MODEL NUMBER 17748/17796 |
| Classification | Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
| Applicant | PHARMACIA DEUTSCHLAND GMBH MUNZINGER STRASSE 7 Freiburg, DE 79111 |
| Contact | Michael Linss |
| Correspondent | Michael Linss PHARMACIA DEUTSCHLAND GMBH MUNZINGER STRASSE 7 Freiburg, DE 79111 |
| Product Code | MOB |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-22 |
| Decision Date | 2004-07-02 |
| Summary: | summary |