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Branan Medical Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K122633TOXCUP DRUG SCREEN CUPFebruary 7, 2013
K122752FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARDJanuary 30, 2013
K040203MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEMarch 25, 2004
K032057TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THCAugust 21, 2003
K030113MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEJuly 2, 2003
K023489QUICKTOX MULTIPLE DRUG DIPCARDDecember 16, 2002
K022355QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61July 30, 2002
K013124MODIFICATION TO SCOOPER DRUG/ADULTERATION TEST CUPNovember 7, 2001
K012541MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TESeptember 4, 2001
K010734BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MODEL MC21 AND MD21July 30, 2001
K004034MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12March 8, 2001
K002263BRANAN MEDICAL CORPORARTION MONITECT THC DRUG SCREEN TESTNovember 27, 2000
K002272BRANAN MEDICAL CORPORATION MONITECT PCP DRUG SCREEN TEST, MODEL 160C AND 160DNovember 22, 2000