510(k) K992243 ยท MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT
| Applicant | Hemagen Diagnostics, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Aug 30, 1999 |
| Received | Jul 1, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992243
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.