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Innotron of Oregon, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
28
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K903101INNOFLUOR (TM) AMIKACIN CALIBRATOR SETAugust 22, 1990
K903100INNOFLUOR (TM) AMIKACIN REAGENT SETAugust 9, 1990
K900707MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATORApril 20, 1990
K900708MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATORApril 19, 1990
K900704MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRAApril 12, 1990
K900706MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRAApril 12, 1990
K900703MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATORApril 12, 1990
K900705MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATORApril 12, 1990
K900702MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRAApril 12, 1990
K895827INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SETOctober 31, 1989
K895826INNOFLUOR DIGOXIN CALIBRATOR SETOctober 30, 1989
K895828INNOFLUOR DIGOXIN REAGENT SETOctober 30, 1989
K893506INNOFLUOR CARBAMAZEPINE CALIBRATOR SETAugust 15, 1989
K893507INNOFLUOR CARBAMAZEPINE REAGENT SETAugust 11, 1989
K892208INNOFLUOR(TM) QUINIDINE REAGENT SETJune 9, 1989
K892212INNOFLUOR(TM) QUINDINE CALIBATOR SETJune 9, 1989
K872563INNOTRON INNOFLUOR PHEYTOIN REAGENT SETAugust 21, 1987
K872562INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SETAugust 17, 1987
K872579INNOFLUOR VANCOMYCIN REAGENT SETAugust 17, 1987
K872142INNOFLUOR PHENYTOIN CALIBRATOR SETJuly 21, 1987