ASTORIA-PACIFIC, INC.

Registration Details

Registration Name: ASTORIA-PACIFIC, INC.
Registration Number: 3050015
FEI Number: 3050015
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: 15130 S.E. 82ND DR.
City: Clackamas
State: OR
ZIP: 97015
Country: US

Regulatory Submissions

510(k) Number: K891070

Owner / Operator

Firm Name: ASTORIA-PACIFIC, INC.
Operator Number: 3050015
Address: 15130 S.E. 82ND DR.
City: Clackamas
State: OR
Postal Code: 97015
Country: US
Correspondent: Jason C Adams

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine	JNB	Class 2	Clinical Chemistry	No	2007-11-09
Enzyme Controls (Assayed And Unassayed)	JJT	Class 1	Clinical Chemistry	No	2010-11-22
1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine	CDR	Class 1	Clinical Chemistry	No	2007-11-09
Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase	KQP	Class 2	Clinical Chemistry	No	2007-11-09
System, Test, Biotinidase	NAK	Class 2	Clinical Chemistry	No	2011-10-07
Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use	JJC	Class 1	Clinical Chemistry	No	2011-10-07
Enzymatic Methods, Galactose	JIA	Class 1	Clinical Chemistry	No	2011-10-07
Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative	JBL	Class 2	Hematology	No	2011-10-07
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	KLI	Class 2	Clinical Chemistry	No	2016-07-12
Analyzer, Chemistry, Micro, For Clinical Use	JJF	Class 1	Clinical Chemistry	No	2010-04-16
Radioimmunoassay, Thyroid-Stimulating Hormone	JLW	Class 2	Clinical Chemistry	No	2016-07-12
Colorimeter, Photometer, Spectrophotometer For Clinical Use	JJQ	Class 1	Clinical Chemistry	No	2011-10-07
Radioimmunoassay, 17-Hydroxyprogesterone	JLX	Class 1	Clinical Chemistry	No	2016-07-12
Multi-Analyte Controls Unassayed	OHQ	Class 1	Clinical Chemistry	No	2018-10-12

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 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 Accuwell 17-OHP Neonatal Screening EIA PRIME 17-OHP Neonatal Screening EIA BioDominium Diagnostics 17-OHP Neonatal Screening EIA SPOTCHECK 17-OHP Neonatal Screening Kit SPOTCHECK Biotinidase 50 hour kit SPOTCHECK MS/MS Blood Spot Controls

Establishment Types

Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198