Medical Device Manufacturer · US , Oklahoma City , OK

Zymetx, Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1996

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Zymetx, Inc. Microbiology ✕

4 devices

1-4 of 4

Cleared Mar 04, 1999

VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES

Microbiology · 66d

Cleared Aug 25, 1998

ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES

Microbiology · 43d

Cleared Sep 10, 1997

VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES

Microbiology · 139d

Cleared Jun 17, 1996

VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES

Microbiology · 479d