510(k) K111335 ยท CKG Radioimmunoassay, Acth
ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321
| Applicant | Tosoh Bioscience, Inc., South San Franciso CA, US |
| Decision | Substantially Equivalent, Dec 1, 2011 |
| Received | May 12, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111335
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 30, 2018 | Tosoh Bioscience Inc ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Adrenocorticotropic hormone (ACTH) in human EDT A plasma. Measurem Terminated |
CKG | None listed |
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.