The following data is part of a premarket notification filed by Hemagen Diagnostics, Inc. with the FDA for Virgo B2 Glycoprotein I Iga Antibody Kit.
| Device ID | K992241 |
| 510k Number | K992241 |
| Device Name: | VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT |
| Classification | System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) |
| Applicant | HEMAGEN DIAGNOSTICS, INC. 40 BEAR HILL RD. Waltham, MA 02451 |
| Contact | Joseph M Califano |
| Correspondent | Joseph M Califano HEMAGEN DIAGNOSTICS, INC. 40 BEAR HILL RD. Waltham, MA 02451 |
| Product Code | MSV |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-01 |
| Decision Date | 1999-08-30 |
| Summary: | summary |