Medical Device Manufacturer · US , Clakamas , OR

Astoria-Pacific, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 1997

9

Total

9

Cleared

0

Denied

Astoria-Pacific, Inc. — FDA 510(k) Products and Clearance History Chemistry ✕

8 devices

1-8 of 8

Cleared Jun 20, 2013

SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT

Chemistry · 435d

Cleared Jul 15, 2011

SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT

Chemistry · 304d

Cleared Feb 04, 2011

NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D

Chemistry · 262d

Cleared Dec 14, 2009

SPOTCHECK BLOOD SPOT CONTROL, ASSAYED

Chemistry · 255d

Cleared Nov 04, 2008

ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT

Chemistry · 274d

Cleared Sep 21, 2001

ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K

Chemistry · 184d

Cleared Mar 19, 1998

TYROSINE 50-HOUR REAGENT KIT

Chemistry · 433d

Cleared Dec 11, 1997

URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K)

Chemistry · 322d