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510(k) K051071

VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT by Viramed Biotech AG — Product Code LSR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2005
Date Received
April 26, 2005
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

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  • 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)

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