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510(k) K221114

Immunoglobulin G (IgG) by Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. — Product Code CFN

K221114 is an FDA 510(k) premarket notification submitted by Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. for the device "Immunoglobulin G (IgG)". The FDA issued a decision of Substantially Equivalent on August 2, 2023. The device falls under product code CFN (Method, Nephelometric, Immunoglobulins (G, A, M)), a Class II device regulated under 21 CFR 866.5510. Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2023
Date Received
April 15, 2022
Clearance Type
Traditional
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 Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.

  • K220977 — ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer (July 20, 2023)

Other clearances for product code CFN

  • K233663 — N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) (December 13, 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