Medical Device Manufacturer · US , Santa Ana , CA

Irvine Scientific Sales Co., Inc.

40 submissions · 40 cleared · Since 1997
40
Total
40
Cleared
0
Denied

Irvine Scientific Sales Co., Inc. — FDA 510(k) Submissions

Irvine Scientific Sales Co., Inc. has submitted 40 FDA 510(k) premarket notifications since 1997, of which 40 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Media, Reproductive, System, Water, Reproduction, Assisted, And Purification, Microtools, Assisted Reproduction (pipettes), Chromatographic Separation, Lecithin/sphingomyelin Ratio, Cannula, Manipulator/injector, Uterine . Use the specialty filter in the sidebar to narrow results.

40 devices
1–25 of 40
Arctic Sperm Cryopreservation Medium
K171224 · MQL Media, Reproductive · Obstetrics & Gynecology
Aug 2017 127d
Continuous Single Culture -NX (CSCM-NX)
K170681 · MQL Media, Reproductive · Obstetrics & Gynecology
Jun 2017 94d
Continuous Single Culture-NX Complete (CSCM-NXC)
K170602 · MQL Media, Reproductive · Obstetrics & Gynecology
Jun 2017 98d
CONTINUOUS SINGLE CULTURE COMPLETE
K121572 · MQL Media, Reproductive · Obstetrics & Gynecology
Jul 2012 51d
MULTIPURPOSE HANDLING MEDIUM
K121128 · MQL Media, Reproductive · Obstetrics & Gynecology
Jun 2012 54d
VIT KIT - FREEZE AND THAW
K093273 · MQL Media, Reproductive · Obstetrics & Gynecology
Mar 2010 135d
SINGLE STEP MEDIUM
K072609 · MQL Media, Reproductive · Obstetrics & Gynecology
Feb 2008 148d
LYOPHILIZED MULTIBLAST MEDIUM KIT
K072608 · MQL Media, Reproductive · Obstetrics & Gynecology
Jan 2008 135d
LYOPHILIZED EARLY CLEAVAGE MEDIUM (ECM) KIT
K072607 · MQL Media, Reproductive · Obstetrics & Gynecology
Jan 2008 130d
AMNIOSTAT-FLM-PG
K061549 · JHG Chromatographic... · Chemistry
Oct 2006 135d
WALLACE ARTIFICIAL INSEMINATION CATHETER
K061679 · LKF Cannula,... · Obstetrics & Gynecology
Oct 2006 120d
VITRIFICATION FREEZE KIT, VITRIFICATION THAW KIT
K060168 · MQL Media, Reproductive · Obstetrics & Gynecology
Apr 2006 91d
CRYOTIP
K041562 · MQH Microtools, Assisted... · Obstetrics & Gynecology
Aug 2004 60d
MULTIBLAST MEDIUM
K034063 · MQL Media, Reproductive · Obstetrics & Gynecology
Apr 2004 117d
EARLY CLEAVAGE MEDIUM (ECM)
K033462 · MQL Media, Reproductive · Obstetrics & Gynecology
Jan 2004 76d
PHENOL RED STOCK SOLUTION
K032887 · MQL Media, Reproductive · Obstetrics & Gynecology
Dec 2003 94d
HYALURONIDASE SOLUTION
K022931 · MQL Media, Reproductive · Obstetrics & Gynecology
Nov 2002 61d
EMBRYO BIOPSY MEDIUM
K021358 · MQL Media, Reproductive · Obstetrics & Gynecology
Jul 2002 67d
EMBRYO FREEZE MEDIUM, EMBRYO THAW MEDIUM
K013518 · MQL Media, Reproductive · Obstetrics & Gynecology
Jan 2002 87d
OIL FOR EMBRYO CULTURE
K011938 · MQL Media, Reproductive · Obstetrics & Gynecology
Jul 2001 27d
WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE
K011598 · MTW System, Water,... · Obstetrics & Gynecology
Jun 2001 20d
COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPLEMENT, MODEL 9922
K003278 · MQL Media, Reproductive · Obstetrics & Gynecology
Jan 2001 90d
DEXTRAN SERUM SUPPLEMENT (DSS), MODEL 9301
K003448 · MQL Media, Reproductive · Obstetrics & Gynecology
Dec 2000 31d
BLASTOCYST FREEZE MEDIUM, BLASTOCYST THAW MEDIUM
K000309 · MQL Media, Reproductive · Obstetrics & Gynecology
Mar 2000 41d
TYRODE'S SOLUTION-ACIDIFIED
K991339 · MQL Media, Reproductive · Obstetrics & Gynecology
Dec 1999 231d
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