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510(k) K974226

IMMUNODOT MONO-G TEST by Genbio — Product Code LSE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 1998
Date Received
November 12, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Epstein-Barr Virus, Other
Device Class
Class I
Regulation Number
866.3235
Review Panel
MI
Submission Type

Other clearances by Genbio

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  • K973941 — IMMUNOWELL EBNA IGG TEST (August 10, 1998)
  • K973939 — IMMUNOWELL VCA IGM 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)
  • K953682 — IMMUNO DOT BORRELIA DOT BLOT G TEST (May 3, 1996)

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