510(k) K092757 ยท MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR
| Applicant | Thera-Test Laboratories, Inc., Lombard IL, US |
| Decision | Substantially Equivalent, Oct 9, 2009 |
| Received | Sep 9, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K092757
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.