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510(k) K984596

VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES by Zymetx, Inc. — Product Code GNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1999
Date Received
December 28, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Neutralization, Influenza Virus A, B, C
Device Class
Class I
Regulation Number
866.3330
Review Panel
MI
Submission Type

Other clearances by Zymetx, Inc.

  • 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)
  • K950838 — VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES (June 17, 1996)