Irvine Scientific

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
16
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K160006Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, EmbryMay 4, 2016
K914541SPERM MAINTENANCE MEDIUM WITH GLYCEROLFebruary 3, 1994
K900316MODIFIED HAM'S F-10 MEDIUM AND MEDIUM-HEPESApril 16, 1990
K894405HTF WITH ALBUMIN (CATALOG NO. 9994)September 22, 1989
K894432MODIFIED HAM'S F-10 W/ALBUMINSeptember 22, 1989
K874668SPERM WASHING MEDIUM #9983 & MODIFIED #9984March 31, 1988
K872088FREEZING MEDIUM (TEST YOLK BUFFER W/GLYCEROL)August 14, 1987
K872203CAT. #9972 REFRIGERATION MEDIUM (TEST YOLK BUFFER)August 14, 1987
K872102SPERM WASHING MEDIUM #9932July 16, 1987
K871577HTF MEDIUM AND MODIFIED HTF MEDIUM-HEPESJuly 15, 1987
K861188SPERM CAPACITATION MEDIUMJanuary 6, 1987
K851820SPINAL FLUID CONTROLJuly 15, 1985
K821560LEVEL II LIPID CONTROLJuly 13, 1982
K821559LEVEL I LIPID CONTROLJuly 13, 1982
K821557LEVEL I CONTROL SERUMJuly 8, 1982
K821558LEVEL II CONTROL SERUMJuly 2, 1982