Casco Standards

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
38
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K981436DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109April 24, 1998
K972904DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROLFebruary 20, 1998
K962629DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATORSeptember 13, 1996
K962630DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROLJuly 22, 1996
K961750DOCUMENT CARDIAC ASSAYED CONTROLJuly 22, 1996
K960244DOCUMENT TDM ULTRA ASSAYED CONTROLMarch 22, 1996
K955155DOCUMENT TDM ULTRA UNASSAYED CONTROLDecember 20, 1995
K950469DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SETApril 11, 1995
K945718DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SETJanuary 17, 1995
K945315DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROLDecember 9, 1994
K944361DOCUMENT R AMMONIA/ETHANOL CONTROLNovember 30, 1994
K944338DOCUMENT R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST SETNovember 15, 1994
K944639DOCUMENTR AMMONIA/ETHANOLCALIBRATORNovember 15, 1994
K940568DOCUMENT(R) ZEROApril 5, 1994
K932870DOCUMENT CHEM IV CALIBRATION VERIFICATION TEST SETAugust 2, 1993
K932458DOCUMENT ENZYMEJune 29, 1993
K931139DOCULMENT(R) CHEM VI CALIBRATION VERIF TEST SETMay 12, 1993
K924493DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MODJanuary 11, 1993
K923821DOCUMENT CHEM V CALIBRATION VERIFICATION TEST SETNovember 5, 1992
K923795DOCUMENT CHEM I CALIBRATION VERIFICATION TEST SETNovember 5, 1992