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510(k) K213510

IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA by Siemens Healthcare Diagnostics Products, Ltd. — Product Code LTK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2023
Date Received
November 2, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Device Class
Class II
Regulation Number
866.6010
Review Panel
IM
Submission Type

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Other clearances for product code LTK

  • K240479 — Access OV Monitor (May 10, 2024)
  • K221355 — VITROS Immuodiagnostic Products CA 125 II Reagent Pack (December 12, 2022)
  • K200199 — ADVIA Centaur CA 125II (April 6, 2020)
  • K143534 — Elecsys CA-125 II assay (August 6, 2015)
  • K142895 — LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULS (May 21, 2015)
  • K100321 — DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 C (April 12, 2011)
  • K080469 — VIDAS CA 15-3 ASSAY (June 22, 2009)
  • K080561 — VIDAS CA 125 II ASSAY (April 10, 2009)
  • K072794 — IMMULITE 2500 OM-MA, MODEL L5KOP (November 5, 2007)
  • K042731 — ARCHITECT CA 125 II ASSAY (November 19, 2004)