The following data is part of a premarket notification filed by Pharmacia Deutschland Gmbh with the FDA for Varelisa Cardiolipin Igg Antibodies, Models 15548 & 15596.
| Device ID | K020752 |
| 510k Number | K020752 |
| Device Name: | VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596 |
| Classification | System, Test, Anticardiolipin Immunological |
| Applicant | PHARMACIA DEUTSCHLAND GMBH MUNZINGERSTRASSE 7 Freiburg, DE |
| Contact | Michael Linss |
| Correspondent | Michael Linss PHARMACIA DEUTSCHLAND GMBH MUNZINGERSTRASSE 7 Freiburg, DE |
| Product Code | MID |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-07 |
| Decision Date | 2002-05-02 |
| Summary: | summary |