Medical Device Manufacturer · US , Mchenry , IL

Atlantic Antibodies

18 submissions · 18 cleared · Since 1983
18
Total
18
Cleared
0
Denied

Atlantic Antibodies — FDA 510(k) Submissions

Atlantic Antibodies has submitted 18 FDA 510(k) premarket notifications since 1983, of which 18 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Apolipoproteins, C-reactive Protein, Antigen, Antiserum, And Control, Iga, Antigen, Antiserum, Control, Prealbumin, Antigen, Antiserum, Control, Alpha-1-antitrypsin, Antigen, Antiserum, Control . Use the specialty filter in the sidebar to narrow results.

18 devices
1–18 of 18
SPQ TM TEST SYSTEM II FOR CRP
K892526 · DCK C-reactive Protein,... · Immunology
May 1989 28d
SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B
K891154 · MSJ Apolipoproteins · Immunology
Mar 1989 10d
SPQ(TM) ANTIBODY REAGENT SET II FOR TRF
K890563 · DDG Transferrin, Antigen,... · Immunology
Mar 1989 38d
SPQ(TM) ANTIBODY REAGENT SET II FOR IGM
K890561 · CFQ Radioimmunoassay,... · Immunology
Feb 1989 30d
SPQ(TM) ANTIBODY REAGENT SET II FOR IGG
K890416 · DEW Igg, Antigen, Antiserum,... · Immunology
Feb 1989 29d
SPQ(TM) ANTIBODY REAGENT SET II FOR HPT
K890562 · DAD Haptoglobin, Antigen,... · Immunology
Feb 1989 29d
SPQ(TM) ANTIBODY REAGENT SET II FOR AAT
K890415 · DEM Alpha-1-antitrypsin,... · Immunology
Feb 1989 24d
SPQ(TM) ANTIBODY REAGENT SET II FOR C3
K890417 · KTQ Reagent, Complement · Immunology
Feb 1989 24d
SPQ(TM) ANTIBODY REAGENT SET II FOR C4
K890564 · DBI Complement C4, Antigen,... · Immunology
Feb 1989 24d
SPQ(TM) ANTIBODY REAGENT SET II FOR IGA
K890560 · CZP Iga, Antigen, Antiserum,... · Immunology
Feb 1989 22d
SPQ(TM) TEST SYSTEM FOR PREALBUMIN
K884297 · JZJ Prealbumin, Antigen,... · Immunology
Nov 1988 21d
SPQ(TM) TEST SYSTEM FOR MICROALBUMIN
K884298 · JZJ Prealbumin, Antigen,... · Immunology
Nov 1988 21d
MODIFIED SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B
K881898 · MSJ Apolipoproteins · Immunology
Jun 1988 47d
SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B
K870564 · MSJ Apolipoproteins · Immunology
Mar 1987 42d
SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN AL
K870862 · MSJ Apolipoproteins · Immunology
Mar 1987 21d
IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST
K861167 · CZP Iga, Antigen, Antiserum,... · Immunology
Apr 1986 28d
SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN
K851842 · DCK C-reactive Protein,... · Immunology
Jun 1985 40d
AUTOIMMUNE TEST 1/2/3 SYSTEM
K833119 · DHN Antinuclear Antibody,... · Immunology
Nov 1983 69d
Filters
All18 Immunology 18