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510(k) K942172

INFLUENZA A ANTIGEN TEST by Neogenex — Product Code GNW

K942172 is an FDA 510(k) premarket notification submitted by Neogenex for the device "INFLUENZA A ANTIGEN TEST". The FDA issued a decision of Substantially Equivalent on July 6, 1994. The device falls under product code GNW (Antisera, Cf, Influenza Virus A, B, C), a Class I device regulated under 21 CFR 866.3330. Neogenex has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1994
Date Received
May 5, 1994
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 Neogenex

  • K965047 — MINK LUNG CELL CULTURE (February 4, 1997)
  • K960909 — H292 CELL CULTURE (May 30, 1996)
  • K943884 — PRIMARY MONKEY KIDNEY CELL CULTURE (November 28, 1994)
  • K943888 — MDCK CELL CULTURE (November 28, 1994)
  • K943889 — VERO CELL CULTURE (November 28, 1994)
  • K943891 — RD CULTURE CELL (November 28, 1994)
  • K943887 — HUMAN NEWBORN FORESKIN CELL CULTURE (November 28, 1994)
  • K943890 — WI38 CELL CULTURE (November 28, 1994)
  • K943885 — PRIMARY RABBIT KIDNEY CELL CULTURE (November 28, 1994)
  • K943886 — BGM CELL CULTURE (November 28, 1994)

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)
  • K974302 — LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B (April 8, 1998)
  • K973954 — IMAGEN RESPIRATORY SCREEN (December 22, 1997)
  • K962037 — IMAGEN RESPIRATORY SCREEN (December 26, 1996)
  • K942174 — INFLUENZA B ANITGEN TEST (June 30, 1994)

FDA data resources