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510(k) K940018

POLIOVIRUS 1 MONOCLONAL ANTIBODY by Light Diagnostics — Product Code GOE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1995
Date Received
January 4, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Fluorescent, Poliovirus 1-3
Device Class
Class I
Regulation Number
866.3405
Review Panel
MI
Submission Type

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Other clearances for product code GOE

  • K940017 — POLIOVIRUS 3 MONOCLONAL ANTIBODY (September 12, 1995)
  • K940027 — ENTEROVIRUS BLEND MONOCLONAL ANTIBODIES (September 12, 1995)
  • K940473 — ENTEROVIRUS 71 MONOCLONAL ANTIBODY (September 12, 1995)
  • K940026 — POLIOVIRUS BLEND MONOCLONAL ANTIBODIES (September 12, 1995)
  • K940034 — POLIOVIRUS 2 MONOCLONAL ANTIBODY (September 12, 1995)
  • K940363 — ENTEROVIRUS 70 MONCLONAL ANTIBODY (September 8, 1995)