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Medical Diagnostic Technologies, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
57
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K062229CTC WORKSTATION, MODEL 2200September 11, 2006
K972209SPECTROLYSE HEPARIN (ANTI-IIA)August 12, 1997
K963106CHROMOLIZE PAI-1 KITNovember 18, 1996
K960871SPECTROLYSE ANTITHROMBIN III (ANTI-XA)August 14, 1996
K962489CHROMOLIZE TPA ASSAY KITJuly 31, 1996
K960438TINTELIZE PAI-1 KITJune 5, 1996
K961724U-DOA CONTROLSJune 3, 1996
K961370LA POSITIVE CONTROL PLASMAMay 24, 1996
K955115VENOM TIEM REAGENTApril 3, 1996
K955738BIOCLOT PROTEIN SFebruary 29, 1996
K952746ALKALINE PHOSPHATASE REAGENT SYSTEMNovember 27, 1995
K952743ASPARTATE AMINOTRANSFERASE REAGENT SYSTEMSeptember 29, 1995
K952741TRIGLYCERIDES (GLYCEROL BLANKING) REAGENT SYSTEMAugust 17, 1995
K952742BLOOD UREA NITROGEN REAGENT SYSTEMAugust 11, 1995
K952745CREATINE KINASE REAGENT SYSTEMAugust 11, 1995
K952747LACTATE DEHYDROGENASE REAGENT SYSTEMAugust 7, 1995
K952744ALANINE AMINOTRANSFERASE REAGENT SYSTEMAugust 7, 1995
K942093REMEL RIM STREPTOCOCCUS GROUPING LATEX AGGLUTINATION TESTNovember 28, 1994
K942257DOA-PLUS, DRUGS OF ABUSE CONTROLSSeptember 14, 1994
K940457LIPASE REAGENT SYSTEMJune 2, 1994