The following data is part of a premarket notification filed by Pharmacia Deutschland Gmbh with the FDA for Varelisa Cardiolipin Igm Antibodies, Models 15648 & 15696.
Device ID | K020758 |
510k Number | K020758 |
Device Name: | VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696 |
Classification | System, Test, Anticardiolipin Immunological |
Applicant | PHARMACIA DEUTSCHLAND GMBH MUNZINGERSTRASSE 7 Freiburg, DE |
Contact | Micharl Linss |
Correspondent | Micharl 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 |