510(k) K030397 ยท MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA
| Applicant | Hycor Biomedical , Ltd., Penicuik, Midlothian, GB |
| Decision | Substantially Equivalent, Mar 21, 2003 |
| Received | Feb 6, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030397
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.