Home / 510(k) Clearances / K233663

510(k) K233663

N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) by Siemens Healthcare Diagnostics Products GmbH — Product Code CFN

K233663 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics Products GmbH for the device "N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)". The FDA issued a decision of Substantially Equivalent on December 13, 2023. The device falls under product code CFN (Method, Nephelometric, Immunoglobulins (G, A, M)), a Class II device regulated under 21 CFR 866.5510. Siemens Healthcare Diagnostics Products GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2023
Date Received
November 15, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Method, Nephelometric, Immunoglobulins (G, A, M)
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

Other clearances by Siemens Healthcare Diagnostics Products GmbH

  • K240315 — INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Api (October 10, 2024)
  • K233946 — IMMULITE® 2000 BR-MA (March 13, 2024)
  • 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 CFN

  • K221114 — Immunoglobulin G (IgG) (August 2, 2023)
  • K192116 — Human IgA liquid reagent kit for Use on SPAPlus (September 4, 2019)
  • K191985 — Optilite IgA Kit (August 19, 2019)
  • K191635 — Optilite IgM Kit (July 15, 2019)
  • K191465 — Human IgM Kit for use on SPAPlus (June 27, 2019)
  • K190686 — Optilite IgM CSF Kit (May 28, 2019)
  • K183151 — Optilite IgA CSF Kit (January 23, 2019)
  • K162208 — DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent (January 9, 2017)
  • K150526 — Optilite IgG4 Kit (May 30, 2015)
  • K142735 — The Optilite IgG3 kit (December 21, 2014)

FDA data resources