510(k) K981522 ยท JZO System, Test, Thyroid Autoantibody
AIA-PACK TGAB ASSAY
| Applicant | Tosoh Medics, Inc., Foster City CA, US |
| Decision | Substantially Equivalent, Oct 8, 1998 |
| Received | Apr 28, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981522
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2018 | Tosoh Bioscience Inc Tosoh Bioscience AIA Analyte Application Manual (AAM) CD
Part Number: 997027
CD contains analyte application manuals for 47 analyte reagent packs for use with the Tosoh AIA (Automated Immuno-Assay) f Terminated |
JIX | None listed |
| May 15, 2017 | Tosoh Bioscience, Inc. AIA-PACK TgAb CONTROL SET Terminated |
JZO | None listed |
| Feb 23, 2012 | Tosoh Bioscience Inc Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of anti-thyroglobulin antibodies (TgAb) in human serum on specific Terminated |
JZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.