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510(k) K233060

Elecsys Folate III by Roche Diagnostics — Product Code CGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2024
Date Received
September 25, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Folic, Radioimmunoassay
Device Class
Class II
Regulation Number
862.1295
Review Panel
CH
Submission Type

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Other clearances for product code CGN

  • K223590 — Access Folate Assay (August 23, 2023)
  • K192586 — LIAISON® Folate (May 6, 2020)
  • K172201 — Atellica IM Folate Assay (April 12, 2018)
  • K161646 — Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set (November 4, 2016)
  • K141426 — ELECSYS FOLATE III (October 17, 2014)
  • K103716 — ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET (May 12, 2011)
  • K092740 — ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CO (March 5, 2010)
  • K091332 — AIA-PACK RBC FOLATE (October 2, 2009)
  • K082340 — ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELE (June 19, 2009)
  • K060774 — FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208 (April 21, 2006)