Atlantic Antibodies

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K892526SPQ TM TEST SYSTEM II FOR CRPMay 9, 1989
K891154SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO BMarch 16, 1989
K890563SPQ(TM) ANTIBODY REAGENT SET II FOR TRFMarch 3, 1989
K890561SPQ(TM) ANTIBODY REAGENT SET II FOR IGMFebruary 23, 1989
K890416SPQ(TM) ANTIBODY REAGENT SET II FOR IGGFebruary 22, 1989
K890562SPQ(TM) ANTIBODY REAGENT SET II FOR HPTFebruary 22, 1989
K890564SPQ(TM) ANTIBODY REAGENT SET II FOR C4February 17, 1989
K890417SPQ(TM) ANTIBODY REAGENT SET II FOR C3February 17, 1989
K890415SPQ(TM) ANTIBODY REAGENT SET II FOR AATFebruary 17, 1989
K890560SPQ(TM) ANTIBODY REAGENT SET II FOR IGAFebruary 15, 1989
K884298SPQ(TM) TEST SYSTEM FOR MICROALBUMINNovember 2, 1988
K884297SPQ(TM) TEST SYSTEM FOR PREALBUMINNovember 2, 1988
K881898MODIFIED SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN BJune 14, 1988
K870564SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN BMarch 24, 1987
K870862SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN ALMarch 24, 1987
K861167IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TESTApril 25, 1986
K851842SPQ TEST SYSTEM FOR C-REACTIVE PROTEINJune 5, 1985
K833119AUTOIMMUNE TEST 1/2/3 SYSTEMNovember 21, 1983