Medical Device Manufacturer · FI , 20101 Turku

Orion Corp.

21 submissions · 20 cleared · Since 1985
21
Total
20
Cleared
0
Denied

Orion Corp. — FDA 510(k) Submissions

Orion Corp. has submitted 21 FDA 510(k) premarket notifications since 1985, of which 20 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Latex Agglutination Assay, Rubella, System, X-ray, Mammographic, Culture Media, Selective And Differential, Antiserum, Fluorescent, Chlamydia Trachomatis, Apolipoproteins . Use the specialty filter in the sidebar to narrow results.

21 devices
1–21 of 21
RUBALEX, MODIFICATION
K912391 · LQN Latex Agglutination... · Microbiology
May 1992 346d
RESUBMITTED MODIFIED RUBALEX
K901637 · LQN Latex Agglutination... · Microbiology
Apr 1990 17d
RESUBMITTED SCANORA
K884650 · IZF System, X-ray, Tomographic · Radiology
Mar 1989 129d
DENTOCULT SM-STRIP MUTANS
K890199 · JSI Culture Media, Selective... · Microbiology
Mar 1989 43d
MAMEX DC MG11
K881505 · IZH System, X-ray, Mammographic · Radiology
Jun 1988 60d
MAMEX DC MAG MG12
K881506 · IZH System, X-ray, Mammographic · Radiology
Jun 1988 60d
MAMEX DC S SL10/MG14
K874040 · IZH System, X-ray, Mammographic · Radiology
Nov 1987 49d
MODIFIED CHLAMYSET ANTIGEN
K872744 · LJP Antiserum, Fluorescent,... · Microbiology
Sep 1987 74d
CHLAMYSET ANTIBODY EIA
K864457 · LJC Enzyme Linked... · Microbiology
Sep 1987 303d
DENTOCULT-SM CULTURE-PADDLE
K872301 · JSI Culture Media, Selective... · Microbiology
Sep 1987 88d
ORICULT-N CULTURE-PADDLE
K872058 · JSI Culture Media, Selective... · Microbiology
Jun 1987 13d
IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B
K861882 · MSJ Apolipoproteins · Immunology
Oct 1986 167d
IMMUNOCHEMICAL ASSAY OF APOLIPOPROTEIN A1
K861883 · MSJ Apolipoproteins · Immunology
Oct 1986 167d
MYOLEX
K863730 · DDR Myoglobin, Antigen,... · Immunology
Oct 1986 22d
MICROALBUMINURIA ASSAY
K862671 · DCF Albumin, Antigen,... · Immunology
Sep 1986 66d
IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN
K860679 · DCN System, Test, C-reactive... · Immunology
Aug 1986 160d
RUBALEX (REVISED VERSION)
K861881 · LQN Latex Agglutination... · Microbiology
Jun 1986 27d
CHLAMYSET ANTIGEN
K853401 · LJP Antiserum, Fluorescent,... · Microbiology
Apr 1986 259d
RUBALEX
K852788 · LQN Latex Agglutination... · Microbiology
Mar 1986 254d
ROTALEX
K860529 · LIQ Enzyme Linked... · Microbiology
Mar 1986 21d
DENTOCULT CULTURE-PADDLE
K851164 · JJJ Counter (beta, Gamma) For... · Microbiology
Oct 1985 221d
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