Irvine Scientific Sales Co., Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
40
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K171224Arctic Sperm Cryopreservation MediumAugust 31, 2017
K170681Continuous Single Culture -NX (CSCM-NX)June 8, 2017
K170602Continuous Single Culture-NX Complete (CSCM-NXC)June 7, 2017
K121572CONTINUOUS SINGLE CULTURE COMPLETEJuly 19, 2012
K121128MULTIPURPOSE HANDLING MEDIUMJune 6, 2012
K093273VIT KIT - FREEZE AND THAWMarch 3, 2010
K072609SINGLE STEP MEDIUMFebruary 12, 2008
K072608LYOPHILIZED MULTIBLAST MEDIUM KITJanuary 30, 2008
K072607LYOPHILIZED EARLY CLEAVAGE MEDIUM (ECM) KITJanuary 25, 2008
K061549AMNIOSTAT-FLM-PGOctober 18, 2006
K061679WALLACE ARTIFICIAL INSEMINATION CATHETEROctober 13, 2006
K060168VITRIFICATION FREEZE KIT, VITRIFICATION THAW KITApril 24, 2006
K041562CRYOTIPAugust 9, 2004
K034063MULTIBLAST MEDIUMApril 26, 2004
K033462EARLY CLEAVAGE MEDIUM (ECM)January 15, 2004
K032887PHENOL RED STOCK SOLUTIONDecember 19, 2003
K022931HYALURONIDASE SOLUTIONNovember 4, 2002
K021358EMBRYO BIOPSY MEDIUMJuly 5, 2002
K013518EMBRYO FREEZE MEDIUM, EMBRYO THAW MEDIUMJanuary 18, 2002
K011938OIL FOR EMBRYO CULTUREJuly 18, 2001