The following data is part of a premarket notification filed by Pharmacia Deutschland Gmbh with the FDA for Varelisa B2 Glycoprotein I Antibodies Screen, Models 19048 And 19096.
| Device ID | K040452 |
| 510k Number | K040452 |
| Device Name: | VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096 |
| Classification | System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) |
| Applicant | PHARMACIA DEUTSCHLAND GMBH DIAGNOSTICS DIVISION MUNZINGER STRASSE 7 Freiburg, DE D-79111 |
| Contact | Michael Linss |
| Correspondent | Michael Linss PHARMACIA DEUTSCHLAND GMBH DIAGNOSTICS DIVISION MUNZINGER STRASSE 7 Freiburg, DE D-79111 |
| Product Code | MSV |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-20 |
| Decision Date | 2004-05-11 |
| Summary: | summary |