510(k) K971103 ยท KHO Fluorometer, For Clinical Use
AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM
| Applicant | Tosoh Medics, Inc., Foster City CA, US |
| Decision | Substantially Equivalent, Jun 27, 1997 |
| Received | Mar 26, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971103
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 30, 2013 | Tosoh Smd Inc AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyzers, 1000 tips/bag
AIA-Analyzer Tips are disposable pipette tips packaged in bulk quantities and used on Tosoh Terminated |
KHO | None listed |
| Nov 30, 2004 | Tosoh Bioscience, Inc. TOSOH brand AIA-600 II Enzyme Immunoassay Analyzer; Software version 3.12, Catalog Numbers 019359, 019400; Model 019400, Smart Media Terminated |
NIG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.