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510(k) K971494

VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES by Zymetx, Inc. — Product Code GNX

K971494 is an FDA 510(k) premarket notification submitted by Zymetx, Inc. for the device "VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES". The FDA issued a decision of Substantially Equivalent on September 10, 1997. The device falls under product code GNX (Antigens, Cf (Including Cf Control), Influenza Virus A, B, C), a Class I device regulated under 21 CFR 866.3330. Zymetx, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 1997
Date Received
April 24, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Device Class
Class I
Regulation Number
866.3330
Review Panel
MI
Submission Type

Other clearances by Zymetx, Inc.

  • K984596 — VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES (March 4, 1999)
  • K982429 — ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES (August 25, 1998)
  • K950838 — VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES (June 17, 1996)

Other clearances for product code GNX

  • K133411 — ALERE BINAXNOW INFLUENZA A & B CARD (December 5, 2013)
  • K132352 — SAS FLUALERT A & B, SAS INFLUENZA A TEST (August 22, 2013)
  • K131804 — REMEL XPECT FLU A&B (July 12, 2013)
  • K131606 — SOFIA INFLUENZA A+B FIA (July 5, 2013)
  • K131599 — QUICK VUE INFLUENZA (July 5, 2013)
  • K131619 — QUICKVUE INFLUENZA A+B (June 28, 2013)
  • K123182 — OSOM INFLUENZA A&B TEST MODEL 190 (November 5, 2012)
  • K924006 — BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY (December 29, 1992)
  • K901493 — FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B (June 27, 1990)
  • K893579 — FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A (January 16, 1990)

FDA data resources