ClearanceBrief
510(k) K001266 ยท CGN Acid, Folic, Radioimmunoassay

VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA

ApplicantOrtho-Clinical Diagnostics, Inc., Rochester NY, US
DecisionSubstantially Equivalent, May 2, 2000
ReceivedApr 20, 2000
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K001266

DateFirm and productCodeLinked 510(k)
Aug 12, 2024Ortho-Clinical Diagnostics, Inc.
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
Open, Classified		 CGNNone listed
Jul 12, 2018Ortho Clinical Diagnostics Inc
VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266
Open, Classified		 CGNNone listed

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