Sa Scientific, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
201
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K132352SAS FLUALERT A & B, SAS INFLUENZA A TESTAugust 22, 2013
K100227SAS FLUALERT A&B, SAS INFLUENZA A TESTFebruary 23, 2010
K080380SAS INFLUENZA A & B TESTJuly 23, 2009
K061496SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TESTJune 28, 2007
K041441SAS INFLUENZA A TESTJuly 22, 2004
K041439SAS INFLUENZA B TESTJuly 22, 2004
K030628SAS RSV CONTROL KITMarch 17, 2003
K022845SAS RSV TESTJanuary 29, 2003
K022683SAS BLOOD/SERUM/URINE/URINE HCGDecember 16, 2002
K023270SAS STREPALERTOctober 17, 2002
K020438SAS VALUE HCGMarch 8, 2002
K013379SAS STREPALERTDecember 12, 2001
K010522SUREVUE URINE HCGJuly 31, 2001
K010593SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KITApril 5, 2001
K993456SAS STREP A TESTMarch 7, 2000
K990630SAS ADENO TESTAugust 19, 1999
K990842SAS ROTA TESTAugust 9, 1999
K990684MODIFICATION OF SAS SERUM/URINE HCGMay 10, 1999
K990741SAS ONE-STEP PREGNANCYMay 10, 1999
K991193SAS HCG-CHECKMay 4, 1999