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510(k) K950838

VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES by Zymetx, Inc. — Product Code GNT

K950838 is an FDA 510(k) premarket notification submitted by Zymetx, Inc. for the device "VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES". The FDA issued a decision of Substantially Equivalent on June 17, 1996. The device falls under product code GNT (Antigens, Ha (Including Ha 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
June 17, 1996
Date Received
February 24, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Ha (Including Ha 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)
  • K971494 — VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES (September 10, 1997)

Other clearances for product code GNT

  • K913828 — QTEST INFLUENZA A (September 23, 1991)
  • K902609 — DIRECTIGEN FLU A (September 10, 1990)
  • K780275 — INFLUENZA HA ANTIGEN A/USSR (February 28, 1978)
  • K780272 — INFLUENZA HA ANTIGEN (February 28, 1978)

FDA data resources