510(k) K092353 ยท LOL Hepatitis A Test (Antibody And Igm Antibody)
MONOLISA ANTI-HAV IGM EIA
| Applicant | Bio-Rad Laboratories, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Oct 29, 2009 |
| Received | Aug 4, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092353
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2011 | Bio-Rad Laboratories Software CD is labeled in part:
"BLOOD VIRUS DIVISION***BIO-RAD EVOLIS System APF Version 4.4 Software Version 2.00 2009/05***"
The EVOLIS Assay Protocol Files (APF) Software contains assay-specific Terminated |
LFX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.