Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3050015

FEI Number

3050015

Entity Name

ASTORIA-PACIFIC, INC.

City/State/Country

Clackamas, OR, US

Establishment Address

15130 S.E. 82ND DR., Clackamas, OR 97015, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ASTORIA-PACIFIC, INC. (Owner Number: 3050015)

Owner / Operator Contact Address

15130 S.E. 82ND DR., Clackamas, OR 97015, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K990957

PMA Number

N/A

All Registered Proprietary Names

SPOTCHECK Phenylalanine 50 hour kit SPOTCHECK Blood Spot Controls - Bio/GALT SPOTCHECK Tyrosine 50 hour kit SPOTCHECK Uridyltransferase 50 hour SPOTCHECK Flow NeoPac Software 307 Digitial Fluorometer/Photometer PRIME Phenylalanine Neonatal Screening Kit BioDominium Diagnostics Phenylalanine Neonatal Screening Kit SPOTCHECK Phenylalanine Neonatal Screening Kit Accuwell Phenylalanine Neonatal Screening Kit Accuwell T4 Neonatal Screening EIA PRIME T4 Neonatal Screening EIA BioDominium Diagnostics T4 Neonatal Screening EIA SPOTCHECK T4 Neonatal Screening Kit SPOTCHECK Neonatal Total Galactose Microplate Reagent Kit SPOTCHECK Neonatal Screening System MULTI-LAB ANALYZER Accuwell Total Galactose Neonatal Screening Kit PRIME Total Galactose Neonatal Screening Kit BioDominium Diagnostics Total Galactose Neonatal Screening Kit SPOTCHECK Total Galactose Neonatal Screening Kit SPOTCHECK Analyzer SPOTCHECK Total Galactose 50 hr kit SPOTCHECK Analyzer PRIME TSH Neonatal Screening ELISA BioDominium Diagnostics TSH Neonatal Screening ELISA Accuwell TSH Neonatal Screening ELISA SPOTCHECK TSH Neonatal Screening Kit SPOTCHECK Neonatal GALT Microplate Rgt Kit SPOTCHECK Pro SPOTCHECK Biotinidase Plate Rgt Kit SPOTCHECK G6PD 50 hour kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JNB	Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine	Clinical Chemistry	Class 2	862.1555	2007-11-09
JJT	Enzyme Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2010-11-22
CDR	1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine	Clinical Chemistry	Class 1	862.1730	2007-11-09
KQP	Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase	Clinical Chemistry	Class 2	862.1315	2007-11-09
NAK	System, Test, Biotinidase	Clinical Chemistry	Class 2	862.1118	2011-10-07
KQP	Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase	Clinical Chemistry	Class 2	862.1315	2011-10-07
JJC	Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use	Clinical Chemistry	Class 1	862.2150	2011-10-07
JNB	Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine	Clinical Chemistry	Class 2	862.1555	2011-10-07
JIA	Enzymatic Methods, Galactose	Clinical Chemistry	Class 1	862.1310	2011-10-07
JBL	Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative	Hematology	Class 2	864.7360	2011-10-07
CDR	1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine	Clinical Chemistry	Class 1	862.1730	2011-10-07
JNB	Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine	Clinical Chemistry	Class 2	862.1555	2013-02-07
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2016-07-12
JIA	Enzymatic Methods, Galactose	Clinical Chemistry	Class 1	862.1310	2013-10-23
JJC	Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use	Clinical Chemistry	Class 1	862.2150	1992-07-01
JIA	Enzymatic Methods, Galactose	Clinical Chemistry	Class 1	862.1310	2013-02-07
JJF	Analyzer, Chemistry, Micro, For Clinical Use	Clinical Chemistry	Class 1	862.2170	2010-04-16
KQP	Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase	Clinical Chemistry	Class 2	862.1315	2007-11-09
JJC	Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use	Clinical Chemistry	Class 1	862.2150	2010-04-19
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2016-07-12
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2011-10-07
KQP	Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase	Clinical Chemistry	Class 2	862.1315	2011-10-07
NAK	System, Test, Biotinidase	Clinical Chemistry	Class 2	862.1118	2009-11-09
JBL	Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative	Hematology	Class 2	864.7360	2007-11-09

Official Correspondent

Jason Adams

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ASTORIA-PACIFIC, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K882795	Baxter Healthcare Corp	DADE(R) CK-MB IMMUNOASSAY CONTROL	1988-08-29
K971777	Instrumentation Laboratory CO	QUANTEX ASO-CRP-RF CONTROL	1997-05-27
K760211	Instrumentation Laboratory CO	ANALYZER, GLUCOSE/UREA/CREATININE	1976-08-26
K941042	Microgenics Corp.	CEDIA T4 MAB ASSAY	1994-04-26
K082638	Siemens Healthcare Diagnostics, Inc.	ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL	2009-02-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0038-2020	Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands	1	V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.
Z-0022-2025	Qualigen Inc	2	FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Z-0044-2020	Roche Diagnostics Operations, Inc.	2	AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids) Catalog Number: 5694302001
Z-0072-2017	Siemens Healthcare Diagnostics, Inc.	2	ADVIA Centaur XPT Immunoassay System

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3050015. Last updated year: 2026. Please use registration number 3050015 when referencing this establishment in official correspondence.