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Wampole Laboratories

FDA 510(k) & PMA Approved Devices — 12 products

Total Devices12
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K965129 BORRELIA BURGDORFERI IGM ELISA TEST SYSTEMLSR1997-03-26 View
510(k) K965131 BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEMLSR1997-03-26 View
510(k) K911444 RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEMLFX1991-08-30 View
510(k) K882896 ONE-STEP HCGDHA1988-10-31 View
510(k) K883004 MONO-PLUS(TM)KTN1988-08-04 View
510(k) K875101 VIROGEN CMV ANTIBODY TESTLQO1988-03-01 View
510(k) K875161 MAT (TM) MICROALBUMIN TESTDCF1988-02-17 View
510(k) K791309 UCG-LYPHOTESTJHJ1979-07-30 View
510(k) K790986 RF CONTROLSDMR1979-06-28 View
510(k) K781794 BETA-TECJHI1978-12-29 View
510(k) K760336 BIOCEPT-GJHI1976-11-12 View
510(k) K760681 INDIRECT FLUORESCENT (IFA-ANA)DHN1976-10-21 View
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