Home / 510(k) Clearances / K162208

510(k) K162208

DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent by Beckman Coulter, Inc. — Product Code CFN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2017
Date Received
August 5, 2016
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, Inc.

  • K254059 — Access anti-HBc IgM (March 13, 2026)
  • K253687 — Access anti-HBc Total (C39432) Access anti-HBc Total Calibrator (C39433) Access (February 19, 2026)
  • K251995 — Access anti-HAV IgM (January 27, 2026)
  • K250588 — Access Rubella IgG (November 17, 2025)
  • K252580 — iQ200 Series (September 10, 2025)
  • K243846 — Access anti-HAV (September 9, 2025)
  • K243804 — MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/m (August 20, 2025)
  • K250036 — MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg (August 15, 2025)
  • K243483 — Access hsTnI (August 1, 2025)
  • K250084 — MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/m (July 18, 2025)

Other clearances for product code CFN

  • K233663 — N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) (December 13, 2023)
  • 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)
  • K150526 — Optilite IgG4 Kit (May 30, 2015)
  • K142735 — The Optilite IgG3 kit (December 21, 2014)