Zymetx, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
4
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K984596VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIESMarch 4, 1999
K982429ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSESAugust 25, 1998
K971494VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSESSeptember 10, 1997
K950838VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSESJune 17, 1996