Astoria-Pacific, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Astoria-Pacific, Inc.” (first 1997, latest 2013), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 274 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 435 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KQP | Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase | 3 | 3 |
| NAK | System, Test, Biotinidase | 2 | 2 |
| CDR | 1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine | 1 | 1 |
| JBL | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative | 1 | 1 |
| JIA | Enzymatic Methods, Galactose | 1 | 1 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 1 | 1 |
Review panels
- Clinical Chemistry (8)
- Hematology (1)
Most recent Astoria-Pacific, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K121101 | SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT | JIA | 2013-06-20 | 435 |
| K102643 | SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT | KQP | 2011-07-15 | 304 |
| K101392 | NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D | KQP | 2011-02-04 | 262 |
| K090940 | SPOTCHECK BLOOD SPOT CONTROL, ASSAYED | JJT | 2009-12-14 | 255 |
| K080294 | ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT | NAK | 2008-11-04 | 274 |
| K010844 | ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K | NAK | 2001-09-21 | 184 |
| K990957 | ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K | JBL | 1999-05-11 | 50 |
| K970093 | TYROSINE 50-HOUR REAGENT KIT | CDR | 1998-03-19 | 433 |
| K970277 | URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) | KQP | 1997-12-11 | 322 |
Recalls
openFDA lists no recalls under a recalling firm named Astoria-Pacific, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Astoria-Pacific, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Astoria-Pacific, Inc.” (first 1997, latest 2013), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Astoria-Pacific, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Astoria-Pacific, Inc. is 274 days.
Which FDA product codes appear under Astoria-Pacific, Inc.?
The most frequent FDA product codes under this applicant name are KQP (Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase, 3); NAK (System, Test, Biotinidase, 2); CDR (1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine, 1).
Next steps
- See all 9 Astoria-Pacific, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KQP, Astoria-Pacific, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.