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510(k) K190686

Optilite IgM CSF Kit by The Binding Site Group , Ltd. — Product Code CFN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2019
Date Received
March 18, 2019
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

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Other clearances for product code CFN

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  • K191635 — Optilite IgM Kit (July 15, 2019)
  • K191465 — Human IgM Kit for use on SPAPlus (June 27, 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)