Company ยท FI
Orion Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 1992. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LQN | Latex Agglutination Assay, Rubella | 4 |
| IZH | System, X-Ray, Mammographic | 3 |
| JSI | Culture Media, Selective And Differential | 3 |
| LJP | Antiserum, Fluorescent, Chlamydia Trachomatis | 2 |
| MSJ | Apolipoproteins | 2 |
| DCF | Albumin, Antigen, Antiserum, Control | 1 |
| DCN | System, Test, C-Reactive Protein | 1 |
| DDR | Myoglobin, Antigen, Antiserum, Control | 1 |
| IZF | System, X-Ray, Tomographic | 1 |
| JJJ | Counter (Beta, Gamma) For Clinical Use | 1 |
| LIQ | Enzyme Linked Immunoabsorbent Assay, Rotavirus | 1 |
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 4, 1992 | K912391 | RUBALEX, MODIFICATION Orion Corp., FI | LQN |
| Apr 26, 1990 | K901637 | RESUBMITTED MODIFIED RUBALEX Orion Corp., FI | LQN |
| Mar 16, 1989 | K884650 | RESUBMITTED SCANORA Orion Corp., FI | IZF |
| Mar 2, 1989 | K890199 | DENTOCULT SM-STRIP MUTANS Orion Corp., FI | JSI |
| Jun 10, 1988 | K881506 | MAMEX DC MAG MG12 Orion Corp. | IZH |
| Jun 10, 1988 | K881505 | MAMEX DC MG11 Orion Corp. | IZH |
| Nov 23, 1987 | K874040 | MAMEX DC S SL10/MG14 Orion Corp., FI | IZH |
| Sep 22, 1987 | K872744 | MODIFIED CHLAMYSET ANTIGEN Orion Corp., FI | LJP |
| Sep 11, 1987 | K872301 | DENTOCULT-SM CULTURE-PADDLE Orion Corp., FI | JSI |
| Sep 11, 1987 | K864457 | CHLAMYSET ANTIBODY EIA Orion Corp., FI | LJC |
| Jun 10, 1987 | K872058 | ORICULT-N CULTURE-PADDLE Orion Corp., FI | JSI |
| Oct 29, 1986 | K861883 | IMMUNOCHEMICAL ASSAY OF APOLIPOPROTEIN A1 Orion Corp., FI | MSJ |
| Oct 29, 1986 | K861882 | IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B Orion Corp., FI | MSJ |
| Oct 15, 1986 | K863730 | MYOLEX Orion Corp., FI | DDR |
| Sep 18, 1986 | K862671 | MICROALBUMINURIA ASSAY Orion Corp., FI | DCF |
| Aug 4, 1986 | K860679 | IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN Orion Corp., FI | DCN |
| Jun 4, 1986 | K861881 | RUBALEX (REVISED VERSION) Orion Corp., FI | LQN |
| Apr 28, 1986 | K853401 | CHLAMYSET ANTIGEN Orion Corp., FI | LJP |
| Mar 12, 1986 | K852788 | RUBALEX Orion Corp., FI | LQN |
| Mar 4, 1986 | K860529 | ROTALEX Orion Corp., FI | LIQ |
| Oct 29, 1985 | K851164 | DENTOCULT CULTURE-PADDLE Orion Corp., FI | JJJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||