Medical Device Manufacturer · US , Mchenry , IL

Irvine Scientific - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 1982

Recent clearances: Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit, SPERM MAINTENANCE MEDIUM WITH GLYCEROL

16

Total

16

Cleared

0

Denied

FDA 510(k) Regulatory Record - Irvine Scientific Obstetrics & Gynecology ✕

11 devices

1-11 of 11

Cleared May 04, 2016

Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit...

Obstetrics & Gynecology · 121d

Cleared Feb 03, 1994

SPERM MAINTENANCE MEDIUM WITH GLYCEROL

Obstetrics & Gynecology · 846d

Cleared Apr 16, 1990

MODIFIED HAM'S F-10 MEDIUM AND MEDIUM-HEPES

Obstetrics & Gynecology · 83d

Cleared Sep 22, 1989

HTF WITH ALBUMIN (CATALOG NO. 9994)

Obstetrics & Gynecology · 67d

Cleared Sep 22, 1989

MODIFIED HAM'S F-10 W/ALBUMIN

Obstetrics & Gynecology · 67d

Cleared Mar 31, 1988

SPERM WASHING MEDIUM #9983 & MODIFIED #9984

Obstetrics & Gynecology · 139d

Cleared Aug 14, 1987

FREEZING MEDIUM (TEST YOLK BUFFER W/GLYCEROL)

Obstetrics & Gynecology · 74d

Cleared Aug 14, 1987

CAT. #9972 REFRIGERATION MEDIUM (TEST YOLK BUFFER)

Obstetrics & Gynecology · 67d

Cleared Jul 16, 1987

SPERM WASHING MEDIUM #9932

Obstetrics & Gynecology · 45d

Cleared Jul 15, 1987

HTF MEDIUM AND MODIFIED HTF MEDIUM-HEPES

Obstetrics & Gynecology · 83d

Cleared Jan 06, 1987

SPERM CAPACITATION MEDIUM

Obstetrics & Gynecology · 281d