510(k) K022945 ยท MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA
| Applicant | Hycor Biomedical, Inc., Garden Grove CA, US |
| Decision | Substantially Equivalent, Dec 18, 2002 |
| Received | Sep 5, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022945
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.