Medical Device Manufacturer · US , Waukesha , WI

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

6 submissions · 6 cleared · Since 2008

Recent clearances: PROPARAFLU+ASSAY, MODIFICATION TO PROFLU+ ASSAY, PROGASTRO CD ASSAY

View 6 510(k) Devices ↓

6

Total

6

Cleared

0

Denied

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

6 devices

1-6 of 6

Cleared Nov 20, 2009

PROPARAFLU+ASSAY

Microbiology · 221d

Cleared Aug 20, 2009

MODIFICATION TO PROFLU+ ASSAY

Microbiology · 6d

Cleared Apr 16, 2009

PROGASTRO CD ASSAY

Microbiology · 73d

Cleared Nov 07, 2008

PRO HMPV+ ASSAY

Microbiology · 53d

Cleared May 02, 2008

MODIFICATION TO PROFLU+ ASSAY

Microbiology · 21d

Cleared Jan 04, 2008

Microbiology · 67d