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Sun Biomedical Laboratories, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
17
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K023856VISUALINE METHADONE DIPSTRIPTESTAugust 25, 2003
K023648VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORMay 6, 2003
K014089VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATESApril 25, 2002
K020136VISUALINE BARBITURATES DIPSTRIP TESTMarch 20, 2002
K011499VISUALINE AMPHETAMINE DIPSTRIP ASSAYJuly 17, 2001
K010177VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAYMay 17, 2001
K993485VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MODecember 27, 1999
K983790VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINEMarch 1, 1999
K981314VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONESeptember 4, 1998
K972032VISUALINE II METHAMPHETIMINEAugust 12, 1997
K963606VISUALINE COMBO V (COCAINE/THC) TESTOctober 30, 1996
K963408VISUALINE D HCGOctober 18, 1996
K953105VISUALINE II BENZODIAZEPINESOctober 5, 1995
K950445VISUALINE II CANNABINOIDS (THC)May 2, 1995
K950369VISUALINE II COCAINEMarch 21, 1995
K943248VISUALINE II MORPHINE/OPIATES/HEROINJanuary 30, 1995
K943239VISUALINE II HCGDecember 7, 1994