510(k) Report

FDA applicant

Astoria-Pacific, Inc.

Clackamas, OR9 decisions1997–20131 recall

FDA records 9 decisions for Astoria-Pacific, Inc. (Clackamas, OR) from 1997 to 2013: 9 510(k) clearances. Most are in product codes KQP (Fluorescent Proc. (Qual.)…) and NAK (System, Test, Biotinidase). Its devices cite 8 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Astoria-Pacific, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2008: 12009: 12011: 22013: 1
2007high 2 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Astoria-Pacific, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Astoria-Pacific, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • KQPFluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase3decisions
  • NAKSystem, Test, Biotinidase2decisions
  • CDR1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine1decision
  • JIAEnzymatic Methods, Galactose1decision
  • JBLGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative1decision
  • JJTEnzyme Controls (Assayed And Unassayed)1decision

Whose devices does it build on?

Its devices cite 8 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K010844Astoria-Pacific Spotcheck Biotinidase Kit, 50 Hour, Part NO. 80-8000-13KAstoria-Pacific, Inc. · 20012cite it

What has FDA decided for it lately?

  • K121101Spotcheck Neonatal Total Galactose Microplate Reagent KitAstoria-Pacific, Inc. · 2013
  • K102643Spotcheck Neonatal Galt Microplate Reagent KitAstoria-Pacific, Inc. · 2011
  • K101392Neopac Software, 3007 Digital Photometer/Fluorometer Model NA, 307 and 350DAstoria-Pacific, Inc. · 2011
  • K090940Spotcheck Blood Spot Control, AssayedAstoria-Pacific, Inc. · 2009
  • K080294Astoria-Pacific Spotcheck Biotinidase Microplate Reagent KitAstoria-Pacific, Inc. · 2008
  • K010844Astoria-Pacific Spotcheck Biotinidase Kit, 50 Hour, Part NO. 80-8000-13KAstoria-Pacific, Inc. · 2001
  • K990957Astoria-Pacific Spotcheck G6PD Kit 50 HR, Model 80-3000-13KAstoria-Pacific, Inc. · 1999
  • K970093Tyrosine 50-Hour Reagent KitAstoria-Pacific, Inc. · 1998

All 9 as Astoria-Pacific, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K970277Liquid Waste Bottle, Catalog#10291587. The Immulite 2000 systems are continuous…Mar 5, 2015Class II