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510(k) K953682

IMMUNO DOT BORRELIA DOT BLOT G TEST by Genbio — Product Code LSR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1996
Date Received
August 7, 1995
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 Genbio

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  • K973939 — IMMUNOWELL VCA IGM TEST (August 10, 1998)
  • K973941 — IMMUNOWELL EBNA IGG TEST (August 10, 1998)
  • K973940 — IMMUNOWELL EBV VCA IGG TEST (August 10, 1998)
  • K963054 — IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130) (May 5, 1997)
  • K963055 — IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120 (May 2, 1997)
  • K953683 — MMUNO DOT BORRELIA DOT BLOT M TEST (May 3, 1996)

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