Orion Corp.
Medical device manufacturer in 20101 Turku, FI.
21510(k) clearances
0PMA approvals
0recalls
Device types
- LQN Latex Agglutination Assay, Rubella 4
- JSI Culture Media, Selective And Differential 3
- IZH System, X-Ray, Mammographic 3
- LJP Antiserum, Fluorescent, Chlamydia Trachomatis 2
- MSJ Apolipoproteins 2
- JJJ Counter (Beta, Gamma) For Clinical Use 1
- LIQ Enzyme Linked Immunoabsorbent Assay… 1
- DCN System, Test, C-Reactive Protein 1
- DCF Albumin, Antigen, Antiserum, Control 1
- DDR Myoglobin, Antigen, Antiserum, Control 1
- LJC Enzyme Linked Immunoabsorbent Assay… 1
- IZF System, X-Ray, Tomographic 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K912391 | Rubalex, ModificationLQN · Traditional | 05/04/1992SE |
| K901637 | Resubmitted Modified RubalexLQN · Traditional | 04/26/1990SE |
| K884650 | Resubmitted ScanoraIZF · Traditional | 03/16/1989SE |
| K890199 | Dentocult Sm-Strip MutansJSI · Traditional | 03/02/1989SE |
| K881506 | Mamex DC Mag MG12IZH · Traditional | 06/10/1988SE |
| K881505 | Mamex DC MG11IZH · Traditional | 06/10/1988SE |
| K874040 | Mamex DC S SL10/MG14IZH · Traditional | 11/23/1987SE |
| K872744 | Modified Chlamyset AntigenLJP · Traditional | 09/22/1987SE |
| K872301 | Dentocult-Sm Culture-PaddleJSI · Traditional | 09/11/1987SE |
| K864457 | Chlamyset Antibody EiaLJC · Traditional | 09/11/1987SE |
| K872058 | Oricult-N Culture-PaddleJSI · Traditional | 06/10/1987SE |
| K861883 | Immunochemical Assay of Apolipoprotein A1MSJ · Traditional | 10/29/1986SE |
| K861882 | Immunochemical Assay Apolipoprotein BMSJ · Traditional | 10/29/1986SE |
| K863730 | MyolexDDR · Traditional | 10/15/1986SE |
| K862671 | Microalbuminuria AssayDCF · Traditional | 09/18/1986SE |
| K860679 | Immunochemical Assay of C-Reactive ProteinDCN · Traditional | 08/04/1986SN |
| K861881 | Rubalex (Revised Version)LQN · Traditional | 06/04/1986SE |
| K853401 | Chlamyset AntigenLJP · Traditional | 04/28/1986SE |
| K852788 | RubalexLQN · Traditional | 03/12/1986SE |
| K860529 | RotalexLIQ · Traditional | 03/04/1986SE |
| K851164 | Dentocult Culture-PaddleJJJ · Traditional | 10/29/1985SE |