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 |