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Wampole Laboratories

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
12
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K965131BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEMMarch 26, 1997
K965129BORRELIA BURGDORFERI IGM ELISA TEST SYSTEMMarch 26, 1997
K911444RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEMAugust 30, 1991
K882896ONE-STEP HCGOctober 31, 1988
K883004MONO-PLUS(TM)August 4, 1988
K875101VIROGEN CMV ANTIBODY TESTMarch 1, 1988
K875161MAT (TM) MICROALBUMIN TESTFebruary 17, 1988
K791309UCG-LYPHOTESTJuly 30, 1979
K790986RF CONTROLSJune 28, 1979
K781794BETA-TECDecember 29, 1978
K760336BIOCEPT-GNovember 12, 1976
K760681INDIRECT FLUORESCENT (IFA-ANA)October 21, 1976