ClearanceBrief
510(k) K023369 ยท KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

ACCESS TOTAL T4 ASSAY

ApplicantBeckman Coulter, Inc., Chaska MN, US
DecisionSubstantially Equivalent, Dec 9, 2002
ReceivedOct 8, 2002
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K023369

DateFirm and productCodeLinked 510(k)
Apr 22, 2026Beckman Coulter, Inc.
Access Total T4 Calibrator, Catalog No. 33805
Open, Classified		 KLINone listed
Mar 15, 2024Beckman Coulter, Inc.
Access Total T4, REF 33800, IVD, thyroxine reagent assay.
Open, Classified		 KLINone listed
Dec 22, 2012Beckman Coulter Inc.
Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total t
Terminated		 JISNone listed
Aug 16, 2011Beckman Coulter Inc.
Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805, Subsequent Product Code: JIS The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quant
Terminated		 KLINone listed
Apr 12, 2011Beckman Coulter Inc.
Access Total T4 Reagent Kit, Part Number: 33800, Lot Numbers (s): All reagent pack lots The Access Total T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determ
Terminated		 KLINone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.