The following data is part of a premarket notification filed by Hemagen Diagnostics, Inc. with the FDA for Virgo Beta 2 Glycoprotein Igm Antibody Kit.
Device ID | K992243 |
510k Number | K992243 |
Device Name: | VIRGO BETA 2 GLYCOPROTEIN IGM 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 |