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510(k) K940017

POLIOVIRUS 3 MONOCLONAL ANTIBODY by Light Diagnostics — Product Code GOE

K940017 is an FDA 510(k) premarket notification submitted by Light Diagnostics for the device "POLIOVIRUS 3 MONOCLONAL ANTIBODY". The FDA issued a decision of Substantially Equivalent on September 12, 1995. The device falls under product code GOE (Antisera, Fluorescent, Poliovirus 1-3), a Class I device regulated under 21 CFR 866.3405. Light Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 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

Other clearances by Light Diagnostics

  • K991880 — LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY (November 9, 1999)
  • K990141 — LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295 (October 19, 1999)
  • K972975 — LIGHT DIAGNOSTICS RABIES DFA REAGENT (December 22, 1998)
  • K974302 — LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B (April 8, 1998)
  • K951821 — CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY (June 7, 1996)
  • K951799 — VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY (March 20, 1996)
  • K940034 — POLIOVIRUS 2 MONOCLONAL ANTIBODY (September 12, 1995)
  • K940026 — POLIOVIRUS BLEND MONOCLONAL ANTIBODIES (September 12, 1995)
  • K936254 — COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODY (September 8, 1995)
  • K940018 — POLIOVIRUS 1 MONOCLONAL ANTIBODY (September 8, 1995)

Other clearances for product code GOE

  • K940473 — ENTEROVIRUS 71 MONOCLONAL ANTIBODY (September 12, 1995)
  • K940026 — POLIOVIRUS BLEND MONOCLONAL ANTIBODIES (September 12, 1995)
  • K940027 — ENTEROVIRUS BLEND MONOCLONAL ANTIBODIES (September 12, 1995)
  • K940034 — POLIOVIRUS 2 MONOCLONAL ANTIBODY (September 12, 1995)
  • K940018 — POLIOVIRUS 1 MONOCLONAL ANTIBODY (September 8, 1995)
  • K940363 — ENTEROVIRUS 70 MONCLONAL ANTIBODY (September 8, 1995)

FDA data resources