Ind Diagnostic, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K103037IND URINARY TRACT INFECTION (UTI) TEST STRIPSApril 17, 2012
K100031IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10July 19, 2010
K063390URINE CHEMISTRY ANALYZER UR-50March 1, 2007
K060810ONE STEP DRUG TEST - AMP/MET/MOR/THC/COCAugust 7, 2006
K052694ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.December 16, 2005
K052662ONE STEP FSH MENOPAUSAL TESTNovember 30, 2005
K050741IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMATMay 16, 2005
K023638CASSETTE/URINE HCGJanuary 3, 2003