FDA Registration
Active
🇺🇸 United States
SPOTCHECK Flow
Reg #: 3050015
·
FEI: 3050015
·
Expires 2025
Products
7
Proprietary Names
3
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- ASTORIA-PACIFIC,INC.
- Registration Number
- 3050015
- FEI Number
- 3050015
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 15130 S.E. 82ND DR.
- City
- Clackamas
- State
- OR
- ZIP
- 97015
- Country
- US
Regulatory Submissions
- 510(k) Number
- K101392
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 |
|---|---|---|---|---|---|
| System, Test, Biotinidase | NAK | Class 2 | Clinical Chemistry | No | 2011-10-07 |
| Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase | KQP | 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 |
| Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine | JNB | Class 2 | 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 |
| 1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine | CDR | Class 1 | Clinical Chemistry | No | 2011-10-07 |
Proprietary Names
SPOTCHECK Flow
NeoPac Software
307 Digitial Fluorometer/Photometer
Establishment Types
Manufacture Medical Device