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510(k) K072794

IMMULITE 2500 OM-MA, MODEL L5KOP by Siemens Medical Solutions Diagnostics — Product Code LTK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2007
Date Received
October 1, 2007
Clearance Type
Special
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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  • K200199 — ADVIA Centaur CA 125II (April 6, 2020)
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  • 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)
  • K042731 — ARCHITECT CA 125 II ASSAY (November 19, 2004)