Irvine Scientific Sales Co., Inc. - FDA 510(k) Cleared Devices
Recent clearances: Arctic Sperm Cryopreservation Medium, Continuous Single Culture -NX (CSCM-NX), Continuous Single Culture-NX Complete (CSCM-NXC)
40
Total
40
Cleared
0
Denied
FDA 510(k) Regulatory Record - Irvine Scientific Sales Co., Inc. Obstetrics & Gynecology ✕
39 devices
Cleared
Aug 31, 2017
Arctic Sperm Cryopreservation Medium
Obstetrics & Gynecology
127d
Cleared
Jun 08, 2017
Continuous Single Culture -NX (CSCM-NX)
Obstetrics & Gynecology
94d
Cleared
Jun 07, 2017
Continuous Single Culture-NX Complete (CSCM-NXC)
Obstetrics & Gynecology
98d
Cleared
Jul 19, 2012
CONTINUOUS SINGLE CULTURE COMPLETE
Obstetrics & Gynecology
51d
Cleared
Jun 06, 2012
MULTIPURPOSE HANDLING MEDIUM
Obstetrics & Gynecology
54d
Cleared
Mar 03, 2010
VIT KIT - FREEZE AND THAW
Obstetrics & Gynecology
135d
Cleared
Feb 12, 2008
SINGLE STEP MEDIUM
Obstetrics & Gynecology
148d
Cleared
Jan 30, 2008
LYOPHILIZED MULTIBLAST MEDIUM KIT
Obstetrics & Gynecology
135d
Cleared
Jan 25, 2008
LYOPHILIZED EARLY CLEAVAGE MEDIUM (ECM) KIT
Obstetrics & Gynecology
130d
Cleared
Oct 13, 2006
WALLACE ARTIFICIAL INSEMINATION CATHETER
Obstetrics & Gynecology
120d
Cleared
Apr 24, 2006
VITRIFICATION FREEZE KIT, VITRIFICATION THAW KIT
Obstetrics & Gynecology
91d
Cleared
Aug 09, 2004
CRYOTIP
Obstetrics & Gynecology
60d
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