FDA 510(k) Applications Submitted by Irvine Scientific Sales Co., Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K170602 03/01/2017 Continuous Single Culture-NX Complete (CSCM-NXC) Irvine Scientific Sales Co., Inc.
K170681 03/06/2017 Continuous Single Culture -NX (CSCM-NX) Irvine Scientific Sales Co., Inc.
K121128 04/13/2012 MULTIPURPOSE HANDLING MEDIUM IRVINE SCIENTIFIC SALES CO., INC.
K171224 04/26/2017 Arctic Sperm Cryopreservation Medium Irvine Scientific Sales Co., Inc.
K121572 05/29/2012 CONTINUOUS SINGLE CULTURE COMPLETE IRVINE SCIENTIFIC SALES CO., INC.
K093273 10/19/2009 VIT KIT - FREEZE AND THAW IRVINE SCIENTIFIC SALES CO., INC.
K971809 05/15/1997 ISOLATE IRVINE SCIENTIFIC SALES CO., INC.
K000309 02/01/2000 BLASTOCYST FREEZE MEDIUM, BLASTOCYST THAW MEDIUM IRVINE SCIENTIFIC SALES CO., INC.
K991337 04/19/1999 SPERM MAINTENANCE MEDIUM WITH GLYCEROL IRVINE SCIENTIFIC SALES CO., INC.
K991338 04/19/1999 BOVINE SERUM ALBUMIN (BSA) IRVINE SCIENTIFIC SALES CO., INC.
K991339 04/19/1999 TYRODE'S SOLUTION-ACIDIFIED IRVINE SCIENTIFIC SALES CO., INC.
K991341 04/19/1999 ISOLATE, ISOLATE CONCENTRATE, ISOLATE STOCK SOLUTION IRVINE SCIENTIFIC SALES CO., INC.
K991342 04/19/1999 PBS 1X- DULBECCO'S PHOSPHATE BUFFERED SALINE SOLUTION IRVINE SCIENTIFIC SALES CO., INC.
K991343 04/19/1999 PVP (POLYVINYLPYRROLIDONE) IRVINE SCIENTIFIC SALES CO., INC.
K991419 04/23/1999 MODIFIED HAM'S F-10 BASAL MEDIUM, MODIFIED HAMS'S F-10 BASAL MEDIUM HEPES, MODIFIED HAM'S F-10 SUPPLEMENT (50X) IYOPHILI IRVINE SCIENTIFIC SALES CO., INC.
K991420 04/23/1999 MODIFIED HAM'S F-10 WITH ALBUMIN IRVINE SCIENTIFIC SALES CO., INC.
K991421 04/23/1999 FREEZING MEDIUM - TEST YOLK BUFFER (TYB) WITH GLYCEROL, REFRIGERATION MEDIUM - TEST YOLK BUFFER 9TYB) IRVINE SCIENTIFIC SALES CO., INC.
K983579 10/13/1998 SYNTHETIC SERUM SUBSTITUTE (SSS) IRVINE SCIENTIFIC SALES CO., INC.
K983580 10/13/1998 BLASTOCYST MEDIUM IRVINE SCIENTIFIC SALES CO., INC.
K983584 10/13/1998 HUMAN SERUM ALBUMIN (HSA) IRVINE SCIENTIFIC SALES CO., INC.
K983586 10/13/1998 HTF MEDIUM, MODIFIED HTF MEDIUM- HEPES, HTF POWDER (WITHOUT ANTIBIOTICS), MODIFIED HTG POWDER- HEPES (WITHOUT ANTIBODITI IRVINE SCIENTIFIC SALES CO., INC.
K983588 10/13/1998 SPERM WASHING MEDIUM, MODIFIED SPERM WASHING MEDIUM IRVINE SCIENTIFIC SALES CO., INC.
K983589 10/13/1998 P-1 (PREIMPLANTATION STAGE ONE) MEDIUM IRVINE SCIENTIFIC SALES CO., INC.
K060168 01/23/2006 VITRIFICATION FREEZE KIT, VITRIFICATION THAW KIT IRVINE SCIENTIFIC SALES CO., INC.
K021358 04/29/2002 EMBRYO BIOPSY MEDIUM IRVINE SCIENTIFIC SALES CO., INC.
K011598 05/24/2001 WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE IRVINE SCIENTIFIC SALES CO., INC.
K041562 06/10/2004 CRYOTIP IRVINE SCIENTIFIC SALES CO., INC.
K061679 06/15/2006 WALLACE ARTIFICIAL INSEMINATION CATHETER IRVINE SCIENTIFIC SALES CO., INC.
K011938 06/21/2001 OIL FOR EMBRYO CULTURE IRVINE SCIENTIFIC SALES CO., INC.
K022931 09/04/2002 HYALURONIDASE SOLUTION IRVINE SCIENTIFIC SALES CO., INC.
K032887 09/16/2003 PHENOL RED STOCK SOLUTION IRVINE SCIENTIFIC SALES CO., INC.
K072609 09/17/2007 SINGLE STEP MEDIUM IRVINE SCIENTIFIC SALES CO., INC.
K072608 09/17/2007 LYOPHILIZED MULTIBLAST MEDIUM KIT IRVINE SCIENTIFIC SALES CO., INC.
K072607 09/17/2007 LYOPHILIZED EARLY CLEAVAGE MEDIUM (ECM) KIT IRVINE SCIENTIFIC SALES CO., INC.
K003278 10/19/2000 COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPLEMENT, MODEL 9922 IRVINE SCIENTIFIC SALES CO., INC.
K013518 10/23/2001 EMBRYO FREEZE MEDIUM, EMBRYO THAW MEDIUM IRVINE SCIENTIFIC SALES CO., INC.
K033462 10/31/2003 EARLY CLEAVAGE MEDIUM (ECM) IRVINE SCIENTIFIC SALES CO., INC.
K003448 11/06/2000 DEXTRAN SERUM SUPPLEMENT (DSS), MODEL 9301 IRVINE SCIENTIFIC SALES CO., INC.
K034063 12/31/2003 MULTIBLAST MEDIUM IRVINE SCIENTIFIC SALES CO., INC.
K061549 06/05/2006 AMNIOSTAT-FLM-PG IRVINE SCIENTIFIC SALES CO., INC.


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