Medical Device Manufacturer · US , Waukesha , WI

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

10 submissions · 10 cleared · Since 2010

Recent clearances: PRODESSE PROFAST+ ASSAY, PROPARAFLU+ ASSAY, PROADENO+ ASSAY

10

Total

10

Cleared

0

Denied

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

10 devices

1-10 of 10

Cleared Aug 26, 2013

PRODESSE PROFAST+ ASSAY

Microbiology · 39d

Cleared Aug 26, 2013

PROPARAFLU+ ASSAY

Microbiology · 39d

Cleared Aug 14, 2013

PROADENO+ ASSAY

Microbiology · 33d

Cleared Aug 14, 2013

PRO HMPV+ ASSAY

Microbiology · 29d

Cleared Aug 09, 2013

PRODESSE PROFLU+ ASSAY

Microbiology · 30d

Cleared Jan 16, 2013

PROGASTRO SSCS ASSAY

Microbiology · 89d

Cleared Jan 16, 2013

PRO HMPV+ ASSAY

Microbiology · 34d

Cleared Jun 27, 2011

Microbiology · 82d

Cleared Dec 03, 2010

PRODESSE PROADENO

Microbiology · 59d

Cleared Jul 23, 2010

Microbiology · 22d