Medical Device Manufacturer · US , Mchenry , IL

Genetic Systems Corp.

12 submissions · 12 cleared · Since 1984
12
Total
12
Cleared
0
Denied

Genetic Systems Corp. — FDA 510(k) Submissions

Genetic Systems Corp. has submitted 12 FDA 510(k) premarket notifications since 1984, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Device, Microtiter Diluting/dispensing, Colorimeter, Photometer, Spectrophotometer For Clinical Use, Respiratory Syncytial Virus, Antigen, Antibody, Ifa, Reagents, Antibody, Legionella, Direct & Indirect Fluorescent, Nadh Oxidation/nad Reduction, Alt/sgpt . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
GENETIC SYSTEMS MICROPLATE READER
K891767 · JJQ Colorimeter, Photometer,... · Chemistry
Jul 1989 123d
GENETIC SYSTEMS PIPETTOR/DILUTOR
K891765 · JTC Device, Microtiter... · Microbiology
May 1989 38d
GENETIC SYSTEMS MICROPLATE STRIP WASHER
K891766 · JTC Device, Microtiter... · Microbiology
May 1989 38d
GENETIC SYSTEMS MICROPLATE WASHER
K891768 · JTC Device, Microtiter... · Microbiology
May 1989 38d
PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT
K890768 · LYF Pneumocystis Carinii · Microbiology
Mar 1989 34d
GENETIC SYSTEMS RSV REAGENT CONTROL SLIDES
K873564 · LKT Respiratory Syncytial... · Microbiology
Nov 1987 79d
MICROPLATE AUTO-WASHER (MOTORIZED STAGE)
K873542 · JTC Device, Microtiter... · Microbiology
Sep 1987 22d
GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KIT
K870176 · LKT Respiratory Syncytial... · Microbiology
Jul 1987 182d
ALANINE TRANSAMINASE (ALT) TEST KIT
K870879 · CKA Nadh Oxidation/nad... · Chemistry
Mar 1987 15d
GSC 1000
K863566 · JJQ Colorimeter, Photometer,... · Chemistry
Oct 1986 34d
LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT
K852237 · LHL Reagents, Antibody,... · Microbiology
Aug 1985 92d
GENETIC SYS LEGIONELLA IMMUNOFLURORES
K842683 · LHL Reagents, Antibody,... · Immunology
Aug 1984 23d
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