Home / 510(k) Clearances / K233946

510(k) K233946

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

K233946 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics Products, Ltd. for the device "IMMULITE® 2000 BR-MA". The FDA issued a decision of Substantially Equivalent on March 13, 2024. The device falls under product code MOI (System, Test, Immunological, Antigen, Tumor), a Class II device regulated under 21 CFR 866.6010. Siemens Healthcare Diagnostics Products, Ltd. has at least 10 other 510(k) clearances on record.

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

Other clearances by Siemens Healthcare Diagnostics Products, Ltd.

  • K240315 — INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Api (October 10, 2024)
  • K233663 — N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) (December 13, 2023)
  • K213510 — IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA (September 8, 2023)
  • K220728 — vWF Ag (June 2, 2023)
  • K212559 — CardioPhase® hsCRP (December 16, 2022)
  • DEN200067 — INNOVANCE VWF Ac (September 29, 2022)
  • K212379 — N Latex FLC kappa, N Latex FLC lambda (March 2, 2022)
  • K201496 — N Latex FLC kappa, N Latex FLC lambda (October 29, 2021)
  • K193047 — N Latex FLC kappa, N Latex FLC lambda (July 14, 2021)
  • K203270 — IMMULITE/IMMULITE® 1000 Cortisol (January 15, 2021)

Other clearances for product code MOI

  • K240403 — Access BR Monitor (May 9, 2024)
  • K192524 — Lumipulse G CA15-3 (September 4, 2020)
  • K193489 — ADVIA Centaur BR (February 13, 2020)
  • K192777 — ADVIA Centaur CA 15-3 assay (November 22, 2019)
  • 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)

FDA data resources