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510(k) K974302

LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B by Light Diagnostics — Product Code GNW

K974302 is an FDA 510(k) premarket notification submitted by Light Diagnostics for the device "LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B". The FDA issued a decision of Substantially Equivalent on April 8, 1998. The device falls under product code GNW (Antisera, Cf, Influenza Virus A, B, C), a Class I device regulated under 21 CFR 866.3330. Light Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1998
Date Received
November 17, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Cf, Influenza Virus A, B, C
Device Class
Class I
Regulation Number
866.3330
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)
  • K951821 — CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY (June 7, 1996)
  • K951799 — VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY (March 20, 1996)
  • K940017 — POLIOVIRUS 3 MONOCLONAL ANTIBODY (September 12, 1995)
  • 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 GNW

  • K092882 — D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT (October 21, 2009)
  • K092300 — MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT (August 28, 2009)
  • K081746 — D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT (December 23, 2008)
  • K061101 — D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT (November 20, 2006)
  • K022713 — DFA RESPIRATORY VIRUS SCREENING & ID KIT (December 18, 2002)
  • K003204 — BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT (November 7, 2000)
  • K973954 — IMAGEN RESPIRATORY SCREEN (December 22, 1997)
  • K962037 — IMAGEN RESPIRATORY SCREEN (December 26, 1996)
  • K942172 — INFLUENZA A ANTIGEN TEST (July 6, 1994)
  • K942174 — INFLUENZA B ANITGEN TEST (June 30, 1994)

FDA data resources