Medical Device Manufacturer · US , Mountain View , CA

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

10 submissions · 10 cleared · Since 1991

10

Total

10

Cleared

0

Denied

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

10 devices

1-10 of 10

Cleared Sep 20, 1994

PROSPECT MICROPLATE ASSAY

Microbiology · 370d

Cleared Sep 09, 1994

PROSPECT GIARDIA

Microbiology · 148d

Cleared May 13, 1993

PROSPECT(TM) GIARDIA RAPID ASSAY, MODIFICATION

Microbiology · 69d

Cleared Apr 21, 1993

PROSPEC T GIARDIA MICROTITER ASSAY

Microbiology · 84d

Cleared Sep 11, 1992

PROSPECT GIARDIA CONTROLS

Microbiology · 99d

Cleared Jun 19, 1992

PROSPECT(TM) GIARDIA MICROTITER ASSAY/MODIFICATION

Microbiology · 50d

Cleared Apr 22, 1992

MODIFICATION PROSPECT GIARDIA RAPID ASSAY

Microbiology · 76d

Cleared Mar 23, 1992

PROSPECT(TM/CRYPTOSPORIDIUM

Microbiology · 307d

Cleared Jan 30, 1992

PROSPECT(TM) GIARDIA RAPID ASSAY

Microbiology · 79d

Cleared Sep 27, 1991

PROSPEC T/GIARDIA RAPID ASSAY

Microbiology · 185d