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510(k) K150526

Optilite IgG4 Kit by The Binding Site Group , Ltd. — Product Code CFN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2015
Date Received
March 2, 2015
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)
  • 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)
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