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510(k) K220016

Viramed Borrela All-In-One ViraChip Test Kit by Viramed Biotech AG — Product Code LSR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2022
Date Received
January 5, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Borrelia Serological Reagent
Device Class
Class II
Regulation Number
866.3830
Review Panel
MI
Submission Type

Other clearances by Viramed Biotech AG

  • K163695 — Borrelia B31 ViraChip IgM Test Kit (August 22, 2017)
  • K163504 — Borrelia B31 ViraChip IgG Test Kit (July 12, 2017)
  • K092693 — VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS (November 25, 2009)
  • K082329 — VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE (August 5, 2009)
  • K051169 — BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT (August 11, 2005)
  • K051071 — VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT (August 11, 2005)

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