Orion Corp.
20101 Turku, FI
Orion Corp. appears in FDA device records in 20101 Turku, FI. FDA records list 19 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 19
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 19 510(k) clearances for Orion Corp. between 1985 and 1992. The busiest year on record is 1986, with 9. The most recent is 1992, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1986 | 9 |
| 1987 | 5 |
| 1989 | 2 |
| 1990 | 1 |
| 1992 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K912391 | RUBALEX, MODIFICATION | LQN | Substantially Equivalent | |
| K901637 | RESUBMITTED MODIFIED RUBALEX | LQN | Substantially Equivalent | |
| K884650 | RESUBMITTED SCANORA | IZF | Substantially Equivalent | |
| K890199 | DENTOCULT SM-STRIP MUTANS | JSI | Substantially Equivalent | |
| K874040 | MAMEX DC S SL10/MG14 | IZH | Substantially Equivalent | |
| K872744 | MODIFIED CHLAMYSET ANTIGEN | LJP | Substantially Equivalent | |
| K872301 | DENTOCULT-SM CULTURE-PADDLE | JSI | Substantially Equivalent | |
| K864457 | CHLAMYSET ANTIBODY EIA | LJC | Substantially Equivalent | |
| K872058 | ORICULT-N CULTURE-PADDLE | JSI | Substantially Equivalent | |
| K861883 | IMMUNOCHEMICAL ASSAY OF APOLIPOPROTEIN A1 | MSJ | Substantially Equivalent | |
| K861882 | IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B | MSJ | Substantially Equivalent | |
| K863730 | MYOLEX | DDR | Substantially Equivalent | |
| K862671 | MICROALBUMINURIA ASSAY | DCF | Substantially Equivalent | |
| K860679 | IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN | DCN | Substantially Equivalent for Some Indications | |
| K861881 | RUBALEX (REVISED VERSION) | LQN | Substantially Equivalent | |
| K853401 | CHLAMYSET ANTIGEN | LJP | Substantially Equivalent | |
| K852788 | RUBALEX | LQN | Substantially Equivalent | |
| K860529 | ROTALEX | LIQ | Substantially Equivalent | |
| K851164 | DENTOCULT CULTURE-PADDLE | JJJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DCFAlbumin, Antigen, Antiserum, Control
- LJPAntiserum, Fluorescent, Chlamydia Trachomatis
- MSJApolipoproteins
- JJJCounter (Beta, Gamma) For Clinical Use
- JSICulture Media, Selective And Differential
- LJCEnzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
- LIQEnzyme Linked Immunoabsorbent Assay, Rotavirus
- LQNLatex Agglutination Assay, Rubella
- DDRMyoglobin, Antigen, Antiserum, Control
- DCNSystem, Test, C-Reactive Protein
- IZHSystem, X-Ray, Mammographic
- IZFSystem, X-Ray, Tomographic
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain