American Bio Medica Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
30
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K170222Rapid Tox Cup IIAugust 15, 2017
K073078RAPID TOX CUPMay 30, 2008
K060760RAPIDONE-BUPRENORPHINE TESTAugust 7, 2006
K053422RAPIDONE-COCAINE-150 TESTJune 15, 2006
K053359RAPIDTOXMay 25, 2006
K041696RAPID READERJuly 12, 2005
K041712'RAPIDTEC 4' TESTNovember 3, 2004
K030835'RAPID ONE' - PROPOXYPHENE TESTMay 22, 2003
K023869'RAPIDTEC'-5M-MULTIPLE DIP TESTApril 30, 2003
K021114'RAPIDTEC' 5A MULTIPLE DIP TESTJuly 23, 2002
K014101RAPIDONE-OXY TESTMarch 20, 2002
K013180RAPIDONE-ECSTASY TESTNovember 26, 2001
K012164'RAPIDONE'-METHADONE TESTNovember 20, 2001
K012159RAPID DRUG SCREENJuly 25, 2001
K002447MODIFICATION TO RAPID DRUG SCREEN 9-PANELNovember 16, 2000
K992451RAPIDONE- BARBITURATE TESTApril 3, 2000
K992720RAPIDONE- BENZODIAZEPINE TESTApril 3, 2000
K993961RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS) AND OPIATES (3 PANEL TESTJanuary 24, 2000
K993151RADID DRUG SCREEN 5-PANEL TESTJanuary 10, 2000
K993796RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJUANA, OPIATES, AMPHETAMINE AND METHADecember 21, 1999