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510(k) K233946

IMMULITE® 2000 BR-MA by Siemens Healthcare Diagnostics Products, Ltd. — Product Code MOI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2024
Date Received
December 14, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Immunological, Antigen, Tumor
Device Class
Class II
Regulation Number
866.6010
Review Panel
IM
Submission Type

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  • K201496 — N Latex FLC kappa, N Latex FLC lambda (October 29, 2021)
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  • K181492 — Elecsys CA 15-3 II (June 22, 2018)
  • K171605 — Elecsys CA 15-3 II (February 20, 2018)
  • K100344 — DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALI (April 18, 2011)
  • K072612 — ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 3876 (October 26, 2007)
  • K042732 — ARCHITECT CA 15-3 ASSAY (December 22, 2004)
  • K033036 — BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 3 (February 3, 2004)