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510(k) K092693

VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS by Viramed Biotech AG — Product Code LSR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2009
Date Received
September 2, 2009
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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  • 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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