Data / Medical devices / United States / Astoria-Pacific, Inc.
Astoria-Pacific, Inc.: FDA-registered device maker in Clackamas, OR, United States, 19 510(k) clearances
Astoria-Pacific, Inc. is registered with the FDA (registration 3050015) in Clackamas, OR, United States. It lists 14 device types. The FDA files 19 510(k) clearances under its listings, the newest dated June 20, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3050015
- Address
- 15130 S.E. 82ND DR., Clackamas, OR, United States, 97015
- Owner or operator
- ASTORIA-PACIFIC, INC. (3050015)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- July 1, 1992
- Registered through
- 2026
- Brand names listed
- 307 Digitial Fluorometer/Photometer, Accuwell 17-OHP Neonatal Screening EIA, Accuwell Phenylalanine Neonatal Screening Kit, Accuwell T4 Neonatal Screening EIA, Accuwell TSH Neonatal Screening ELISA, Accuwell Total Galactose Neonatal Screening Kit, BioDominium Diagnostics 17-OHP Neonatal Screening EIA, BioDominium Diagnostics Phenylalanine Neonatal Screening Kit and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 20, 2013 | K121101 | SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT | JIA | Substantially Equivalent | Astoria-Pacific, Inc. | accessdata.fda.gov |
| July 15, 2011 | K102643 | SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT | KQP | Substantially Equivalent | Astoria-Pacific, Inc. | accessdata.fda.gov |
| February 4, 2011 | K101392 | NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D | KQP | Substantially Equivalent | Astoria-Pacific, Inc. | accessdata.fda.gov |
| December 14, 2009 | K090940 | SPOTCHECK BLOOD SPOT CONTROL, ASSAYED | JJT | Substantially Equivalent | Astoria-Pacific, Inc. | accessdata.fda.gov |
| November 4, 2008 | K080294 | ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT | NAK | Substantially Equivalent | Astoria-Pacific, Inc. | accessdata.fda.gov |
| March 13, 2007 | K060452 | ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH | JLX | Substantially Equivalent | Neo-Genesis | accessdata.fda.gov |
| September 21, 2001 | K010844 | ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K | NAK | Substantially Equivalent | Astoria-Pacific, Inc. | accessdata.fda.gov |
| November 2, 2000 | K001455 | ACCUWELL TSH, MODEL KAW-TSH-960 | JLW | Substantially Equivalent | Neometrics, Inc. | accessdata.fda.gov |
| June 16, 1999 | K991498 | ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL | JIA | Substantially Equivalent | Neometrics, Inc. | accessdata.fda.gov |
| May 11, 1999 | K990957 | ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K | JBL | Substantially Equivalent | Astoria-Pacific, Inc. | accessdata.fda.gov |
| March 19, 1998 | K970093 | TYROSINE 50-HOUR REAGENT KIT | CDR | Substantially Equivalent | Astoria-Pacific, Inc. | accessdata.fda.gov |
| December 11, 1997 | K970277 | URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) | KQP | Substantially Equivalent | Astoria-Pacific, Inc. | accessdata.fda.gov |
| December 5, 1997 | K974047 | ACCUWELL PHENYLALANINE ASSAY | JNB | Substantially Equivalent | Neometrics, Inc. | accessdata.fda.gov |
| October 6, 1997 | K972974 | ACCUWELL T4-EIA | KLI | Substantially Equivalent | Neometrics, Inc. | accessdata.fda.gov |
| January 11, 1990 | K894011 | TOTAL GALACTOSE | KQP | Substantially Equivalent | Alpkem Corp. | accessdata.fda.gov |
| October 27, 1989 | K891070 | PHENYLALANINE (NINHYDRIN REACTION) | JNB | Substantially Equivalent | Alpkem Corp. | accessdata.fda.gov |
| February 17, 1989 | K890332 | RFA/2 RAPID FLOW ANALYZER W/COMPUTER | JJC | Substantially Equivalent | Alpkem Corp. | accessdata.fda.gov |
| September 2, 1988 | K883020 | RFA-300 RAPID FLOW ANALYZER W/COMPUTER | JJF | Substantially Equivalent | Alpkem Corp. | accessdata.fda.gov |
| May 10, 1985 | K851542 | RFA-300 RAPID FLOW ANALYZER W/COMPUTER | JJF | Substantially Equivalent | Alpkem Corp. | accessdata.fda.gov |
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Updated June 20, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.