Applications Lab
Medical device manufacturer in Scarborough, ME.
10510(k) clearances
0PMA approvals
0recalls
Device types
- CZP Iga, Antigen, Antiserum, Control 1
- DEW Igg, Antigen, Antiserum, Control 1
- DBI Complement C4, Antigen, Antiserum, Control 1
- DCK C-Reactive Protein, Antigen, Antiserum, And… 1
- DAD Haptoglobin, Antigen, Antiserum, Control 1
- CZW Complement C3, Antigen, Antiserum, Control 1
- DDG Transferrin, Antigen, Antiserum, Control 1
- DEB Alpha-2-Macroglobulin, Antigen, Antiserum… 1
- DAO Igm (Mu Chain Specific), Antigen… 1
- DEM Alpha-1-Antitrypsin, Antigen, Antiserum… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K850587 | SPQ Test System for Alpha, - AntitrypsinDEM · Traditional | 03/14/1985SE |
| K850586 | SPQ Test System for Immunoglobulin MDAO · Traditional | 03/14/1985SE |
| K850603 | SPQ Test System for ALPHA(2) MacroglobulinDEB · Traditional | 03/05/1985SE |
| K850589 | SPQ Test System for TransferrinDDG · Traditional | 03/05/1985SE |
| K850588 | SPQ Test System for Complement C3CZW · Traditional | 03/05/1985SE |
| K850584 | SPQ Test System for HaptoglobinDAD · Traditional | 03/05/1985SE |
| K850590 | SPQ Test System for C-Reactive ProteinDCK · Traditional | 03/01/1985SE |
| K850585 | SPQ Test System for Complement C4DBI · Traditional | 03/01/1985SE |
| K850583 | SPQ Test System for Immunoglobulin GDEW · Traditional | 03/01/1985SE |
| K850582 | SPQ Test System for Immunoglobulin aCZP · Traditional | 03/01/1985SE |