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510(k) K220001

Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay by Diazyme Laboratories, Inc. — Product Code DFH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2022
Date Received
January 4, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kappa, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5550
Review Panel
IM
Submission Type

Other clearances by Diazyme Laboratories, Inc.

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  • K211648 — Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chai (September 8, 2022)
  • K212221 — Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemilu (December 13, 2021)
  • K203136 — Diazyme PLAC® Test for Lp-PLA2 Activity (August 6, 2021)
  • K180209 — Diazyme 1,5-AG Assay (October 4, 2018)
  • K181438 — Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chai (June 26, 2018)
  • K180074 — Diazyme Lipoprotein (a) Assay (March 22, 2018)
  • K172992 — Diazyme EZ Vitamin D Assay (January 11, 2018)
  • K163418 — Diazyme DZ-Lite Total beta-hCG Test System (August 18, 2017)

Other clearances for product code DFH

  • K253358 — Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Li (December 19, 2025)
  • K250549 — Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit (May 23, 2025)
  • K231601 — FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 (February 23, 2024)
  • K231290 — Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit (January 24, 2024)
  • K210623 — FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 (November 18, 2022)
  • K211648 — Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chai (September 8, 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)
  • K190879 — N Latex FLC kappa, N Latex FLC lambda (May 3, 2019)