Oxis Intl., Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
11
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K972331INNOFLUOR GENTAMICIN ASSAY SYSTEMAugust 1, 1997
K972330INNOFLUOR PHENOBARBITAL ASSAY SYSTEMJuly 14, 1997
K970517INNOFLUOR TOPIRAMATE CONTROL SETMay 12, 1997
K970509INNOFLOUR CALIBRATOR REAGENT SETMay 12, 1997
K970510INNOFLOUR TOPIRAMATE REAGENT SETMay 12, 1997
K955568INNOFLUOR QUINIDINE ASSAY SYSTEMApril 4, 1996
K955569INNOFLUOR GENTAMICIN ASSAY SYSTEMFebruary 9, 1996
K955570INNOFLUOR AMIKACIN ASSAY SYSTEMFebruary 9, 1996
K955567INNOFLUOR THEOPHYLLINE ASSAY SYSTEMJanuary 24, 1996
K955562INNOFLUOR PHENYTOIN ASSAY SYSTEMJanuary 24, 1996
K950346B-L RED(TM) DISCSMay 5, 1995