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Biotrol, USA, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
46
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K934014VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANTDecember 6, 1995
K931141BIOTROL AMYLASE CNPG3May 26, 1993
K921855BIOTROL BICARBONATE STANDARDSAugust 3, 1992
K921677BIOTROL MAGNESIUM (MAGON)May 26, 1992
K912795BIOTROL UIBC REAGENTAugust 12, 1991
K910721BIOTROL PROTEIN MULTILEVEL STANDARDSMay 6, 1991
K905683BIOTROL LACTATE DEHYDROGENASE (L-P)March 11, 1991
K905280BIOTROL BILIRUBIN C & T CONTROLFebruary 4, 1991
K894544BIOTROL RUB-E.I.A. TEST GAugust 30, 1989
K891061BIOTROL CALCIUM MONOREACTIFAugust 10, 1989
K891286BIOTROL CHEMISTRY URINE CONTROLApril 10, 1989
K890846BIOTROL URINE PROTEINS REAGENTMarch 21, 1989
K890395BIOTROL IRON REAGENTMarch 8, 1989
K890015BIOTROL CHLORIDEFebruary 17, 1989
K885094BIOTROL ALBUMINFebruary 10, 1989
K885041BIOTROL INORGANIC PHOSPHORUSJanuary 30, 1989
K885053BIOTROL URINE PROTEINS REAGENTJanuary 30, 1989
K884480BIOTROL BILIRUBIN MONOREACTIFNovember 29, 1988
K883428BIOTROL URIC ACID ENZYMATIQUE TRINDERSeptember 13, 1988
K881742BIOTROL ALKALINE PHOSPHATASEJuly 8, 1988