Astoria-Pacific, Inc.
Clackamas, OR, US
ASTORIA-PACIFIC, INC. appears in FDA device records in Clackamas, OR. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Astoria-Pacific, Inc. between 1997 and 2013. The busiest year on record is 2011, with 2. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
| 1998 | 1 |
| 1999 | 1 |
| 2001 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2011 | 2 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K121101 | SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT | JIA | Substantially Equivalent | |
| K102643 | SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT | KQP | Substantially Equivalent | |
| K101392 | NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D | KQP | Substantially Equivalent | |
| K090940 | SPOTCHECK BLOOD SPOT CONTROL, ASSAYED | JJT | Substantially Equivalent | |
| K080294 | ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT | NAK | Substantially Equivalent | |
| K010844 | ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K | NAK | Substantially Equivalent | |
| K990957 | ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K | JBL | Substantially Equivalent | |
| K970093 | TYROSINE 50-HOUR REAGENT KIT | CDR | Substantially Equivalent | |
| K970277 | URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) | KQP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3050015 | 3050015 | ASTORIA-PACIFIC, INC. | 15130 S.E. 82ND DR., Clackamas, OR 97015 US | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CDR1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine
- JJCAnalyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
- JJFAnalyzer, Chemistry, Micro, For Clinical Use
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- JIAEnzymatic Methods, Galactose
- JJTEnzyme Controls (Assayed And Unassayed)
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- KQPFluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
- JBLGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative
- OHQMulti-Analyte Controls Unassayed
- JNBNinhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
- JLXRadioimmunoassay, 17-Hydroxyprogesterone
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- NAKSystem, Test, Biotinidase
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain