Medical Device Manufacturer · US , Mchenry , IL

Gelman Instrument Co.

11 submissions · 11 cleared · Since 1977
11
Total
11
Cleared
0
Denied

Gelman Instrument Co. — FDA 510(k) Submissions

Gelman Instrument Co. has submitted 11 FDA 510(k) premarket notifications since 1977, of which 11 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Complement C5, Antigen, Antiserum, Control, Iga, Antigen, Antiserum, Control, Igg, Antigen, Antiserum, Control, Haptoglobin, Fitc, Antigen, Antiserum, Control, Igm, Ferritin, Antigen, Antiserum, Control . Use the specialty filter in the sidebar to narrow results.

11 devices
1–11 of 11
RADIAL IMMUNODIFFUSION KIT-COMP. 3
K772073 · DBI Complement C4, Antigen,... · Immunology
Feb 1978 92d
RADIAL IMMUNODIFFUSION KIT-TRANSFERRIN
K772074 · DDI Transferrin, Fitc,... · Immunology
Feb 1978 92d
RADIAL IMMUNODIFFUSION KIT-COMPLEMENT
K772075 · DAY Complement C5, Antigen,... · Immunology
Feb 1978 92d
RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.
K772076 · CZP Iga, Antigen, Antiserum,... · Immunology
Feb 1978 92d
RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.G
K772077 · DEW Igg, Antigen, Antiserum,... · Immunology
Feb 1978 92d
RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBIN
K772078 · DAB Haptoglobin, Fitc,... · Immunology
Feb 1978 92d
RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.M
K772079 · DFL Igm, Ferritin, Antigen,... · Immunology
Feb 1978 92d
RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT
K772080 · DEM Alpha-1-antitrypsin,... · Immunology
Feb 1978 92d
DENSITOMETER 18, COMPUTING, AUTO.
K772325 · JQT Densitometer/scanner... · Chemistry
Jan 1978 24d
LIPPOPROTEIN ELECTROPHORESIS REAGENT SET
K771812 · DFC Lipoprotein, Low-density,... · Immunology
Oct 1977 21d
ALKALINE PHOSPHATASE ISOYZME REAGENT SET
K770155 · CJO Alpha-naphthyl Phosphate,... · Chemistry
Jan 1977 7d
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