Medical Device Manufacturer · US , Mchenry , IL

Gelco Diagnostics, Inc.

14 submissions · 14 cleared · Since 1983
14
Total
14
Cleared
0
Denied

Gelco Diagnostics, Inc. — FDA 510(k) Submissions

Gelco Diagnostics, Inc. has submitted 14 FDA 510(k) premarket notifications since 1983, of which 14 received clearance as substantially equivalent to a predicate device.

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

14 devices
1–14 of 14
GOAT ANTI-HUMAN IMMUNOGLOBULINS-
K832256 · DFH Kappa, Antigen,... · Immunology
Oct 1983 123d
GOAT ANTI-HUMAN IGG Y CHAIN SPECIFIC
K832258 · DEW Igg, Antigen, Antiserum,... · Immunology
Oct 1983 123d
GOAT ANTI-HUMAN KAPPA AFFINITY
K832260 · DEO Kappa, Fitc, Antigen,... · Immunology
Oct 1983 123d
FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS
K832262 · CZN Iga, Fitc, Antigen,... · Immunology
Oct 1983 123d
FITC GOAT ANTI-HUMAN IGA A CHAIN
K832263 · CZP Iga, Antigen, Antiserum,... · Immunology
Oct 1983 123d
FITC GOAT ANTI-HUMAN IGM H CHAIN
K832265 · DFT Igm, Antigen, Antiserum,... · Immunology
Oct 1983 123d
FITC GOAT ANTI-HUMAN KAPPA AFFINITY
K832266 · DFH Kappa, Antigen,... · Immunology
Oct 1983 123d
FITC GOAT ANTI-HUMAN LAMBA
K832267 · DES Lambda, Fitc, Antigen,... · Immunology
Oct 1983 123d
GOAT ANTI-HUMAN LAMBA
K832270 · DEH Lambda, Antigen,... · Immunology
Oct 1983 123d
GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC
K832257 · CZN Iga, Fitc, Antigen,... · Immunology
Oct 1983 120d
GOAT ANTI-HUMAN IGM H CHAIN
K832259 · DFT Igm, Antigen, Antiserum,... · Immunology
Oct 1983 120d
GOAT ANTI-HUMAN LAMBA AFFINITY
K832261 · DEH Lambda, Antigen,... · Immunology
Oct 1983 120d
FITC GOAT ANTI-HUMAN IGG Y CHAIN
K832264 · DEW Igg, Antigen, Antiserum,... · Immunology
Oct 1983 120d
RABBIT ANTI-HUMAN ANTITHROMBIN III
K832268 · JBQ Antithrombin Iii... · Hematology
Aug 1983 43d
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