Product Code: MQL FDA class 2 21 CFR 884.6180

Media, Reproductive

Obstetrics/Gynecology

Reproductive Media are obstetrics/gynecology devices consisting of specialized culture media formulations used to maintain and support the viability, development, and growth of gametes and embryos during ART procedures. Classified as FDA Class 2 under 21 CFR 884.6180, they require 510(k) premarket notification. The product code is MQL.

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510(k)s

259

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MQL
Device Class: FDA class 2
Regulation Number: 884.6180
Medical Specialty: Obstetrics/Gynecology
Review Panel: OB
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 259 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260248	Ultra-Fast Warm	Apr 28, 2026	Substantially Equivalent	Kitazato Corporation
K252672	CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5)	Feb 20, 2026	Substantially Equivalent	Casebioscience, Inc.
K250445	Fast Warm - NX	Sep 12, 2025	Substantially Equivalent	Fujifilm Irvine Scientific
K251637	Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])	Aug 27, 2025	Substantially Equivalent	Donnevie Medical Technology (Shanghai) Co. , Ltd.
K251305	Ultra-Fast Vitri; Ultra-Fast Warm	Aug 26, 2025	Substantially Equivalent	Kitazato Corporation
K242640	FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin	May 30, 2025	Substantially Equivalent	Fertipro NV
K242561	Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)	Apr 10, 2025	Substantially Equivalent	Donnevie Medical Technology (Shanghai) Co. , Ltd.
K242089	Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)	Apr 10, 2025	Substantially Equivalent	Jiangsu Ruifuda Medical Device Co., Ltd.
K242107	CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF)	Mar 21, 2025	Substantially Equivalent	Casebioscience, Inc.
K241833	V-GRAD	Mar 21, 2025	Substantially Equivalent	Vitromed GmbH
K242043	Sperm Freezing Medium	Jan 08, 2025	Substantially Equivalent	Gimbo Medical Technology Shenzhen Co., Ltd.
K241132	ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)	Dec 18, 2024	Substantially Equivalent	Artsmedia Denmark Aps
K241095	ARTSMedia Semen Wash Medium	Dec 18, 2024	Substantially Equivalent	Artsmedia Denmark Aps
K242968	Giftlife® Single-Step Medium Plus	Nov 22, 2024	Substantially Equivalent	Gimbo Medical Technology Shenzhen Co., Ltd.
K240176	V-VITFREEZE and V-VITWARM	Sep 13, 2024	Substantially Equivalent	Vitromed GmbH
K233846	Vitrification Solution Set and Warming Solution Set	Aug 27, 2024	Substantially Equivalent	Ecmpc, LLC
K240605	Ultra RapidWarm Blast	Aug 07, 2024	Substantially Equivalent	Vitrolife Sweden AB
K233477	Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML)	Jul 01, 2024	Substantially Equivalent	Shandong Wego Ruisheng Medical Device Co., Ltd.
K240149	Giftlife Fertilization Medium; Giftlife Cleavage Medium; Giftlife Blastocyst Medium; Giftlife Single Step Medium	Jun 13, 2024	Substantially Equivalent	Gimbo Medical Technology Shenzhen Co., Ltd.
K234023	Oocyte Flushing & Retrieval Medium; Gamete Buffer	May 10, 2024	Substantially Equivalent	Gimbo Medical Technology Shenzhen Co., Ltd.
K233764	SSS-NX (Serum Substitute Supplement-NX)	Apr 24, 2024	Substantially Equivalent	Fujifilm Irvine Scientific
K232125	V-PVP	Mar 20, 2024	Substantially Equivalent	Vitromed GmbH
K232942	G-Vitri Vitrification Freeze Media; G-Vitri Vitrification Thawing Media	Jan 30, 2024	Substantially Equivalent	Gimbo Medical Technology Shenzhen Co., Ltd.
K231370	Dewin Blastocyst Medium (with HSA and without HSA)	Aug 04, 2023	Substantially Equivalent	Donnevie Medical Technology (Shanghai) Co. , Ltd.
K222606	V-HYADASE	May 26, 2023	Substantially Equivalent	Vitromed GmbH
K223265	CryoX Vitrification Freeze Kit / Thaw Kit	May 11, 2023	Substantially Equivalent	Zhejiang Horizon Medical Technology Co., Ltd.
K220715	ARTSMedia In Vitro Culture Medium (AM-IVC Medium)	Feb 10, 2023	Substantially Equivalent	Artsmedia Denmark Aps
K223117	V-SPERM WASH	Jan 31, 2023	Substantially Equivalent	Vitromed GmbH
K213293	V-HEPES PLUS	Sep 14, 2022	Substantially Equivalent	Vitromed Langenfeld
K212426	Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA])	Jun 16, 2022	Substantially Equivalent	Donnevie Medical Technology (Shanghai) Co. , Ltd.
K212410	VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium	Feb 01, 2022	Substantially Equivalent	Shenzhen Vitavitro Biotech Co., Ltd.
K202862	Gx-IVF, Gx-TL, Gx-MOPS PLUS	May 14, 2021	Substantially Equivalent	Vitrolife Sweden AB
K193285	V-ONESTEP	Nov 20, 2020	Substantially Equivalent	Vitromed GmbH
K192503	GM501 Wash with Phenol Red and Gentamicin	Nov 19, 2020	Substantially Equivalent	Hamilton Thorne Incorporated
K200249	Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA])	Oct 23, 2020	Substantially Equivalent	Kitazato Corporation
K200408	VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium	Oct 16, 2020	Substantially Equivalent	Shenzhen Vitavitro Biotech Co., Ltd.
K193522	iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA	Aug 25, 2020	Substantially Equivalent	Kitazato Corporation
K192845	Sperm Freeze, Sperm Fridge	Aug 17, 2020	Substantially Equivalent	Kitazato Corporation
K200680	Synvitro Hyadase	Jul 17, 2020	Substantially Equivalent	Origio A/S, A Coopersurgical Company
K192644	GM501 SpermAir and GM501 SpermActive	Apr 23, 2020	Substantially Equivalent	Hamilton Thorne Incorporated
K190199	SepaSperm Washing Solution, SepaSperm Solution	Sep 26, 2019	Substantially Equivalent	Kitazato Corporation
K191552	GM501 Mineral Oil	Sep 18, 2019	Substantially Equivalent	Hamilton Thorne, Inc.
K190383	GM501 Wash	Sep 05, 2019	Substantially Equivalent	Hamilton Thorne, Inc.
K191063	1-Step Culture Medium	Aug 23, 2019	Substantially Equivalent	Shenzhen Vitavitro Biotech Co., Ltd.
K183486	RapidVit Oocyte, RapidWarm Oocyte	Jul 26, 2019	Substantially Equivalent	Vitrolife Sweden AB
K190152	Vit Kit- Freeze NX and Vit Kit- Warm NX	Jun 21, 2019	Substantially Equivalent	Fujifilm Irvine Scientific, Inc.
K182002	Cumulus Remover	Oct 23, 2018	Substantially Equivalent	Kitazato Corporation
K180073	Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set	Aug 29, 2018	Substantially Equivalent	Shenzhen Vitavitro Bio-Tech Co., Ltd.
K173731	SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031)	Mar 02, 2018	Substantially Equivalent	CooperSurgical, Inc.
K173624	ORIGIO® Handling without phenol red (Cat. No. 8310), ORIGIO® Handling with phenol red (Cat. No. 8311)	Mar 02, 2018	Substantially Equivalent	Origio A/S
K171748	Vitrification Kit and Thawing Kit	Dec 14, 2017	Substantially Equivalent	Kitazato Corporation
K172197	SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS	Oct 13, 2017	Substantially Equivalent	Origio A/S
K170498	Gems Oocyte Retrieval Buffer ORB-20, ORB-50	Sep 28, 2017	Substantially Equivalent	Genea Biomedx Pty, Ltd.
K171224	Arctic Sperm Cryopreservation Medium	Aug 31, 2017	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K170681	Continuous Single Culture -NX (CSCM-NX)	Jun 08, 2017	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K170602	Continuous Single Culture-NX Complete (CSCM-NXC)	Jun 07, 2017	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K162409	Gems Vitrification Set, Gems Warming Set	May 24, 2017	Substantially Equivalent	Genea Biomedx Pty, Ltd.
K161261	Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase	May 12, 2017	Substantially Equivalent	Genea Biomedx Pty, Ltd.
K170560	SAGE Vitrification Kit and SAGE Vitrification Warming Kit	Apr 04, 2017	Substantially Equivalent	CooperSurgical, Inc.
K170257	Sydney IVF Culture Oil	Feb 24, 2017	Substantially Equivalent	William A. Cook Australia Pty. , Ltd.
K160864	Cryotop Vitrification Kit and Cryotop Thawing Kit	Oct 07, 2016	Substantially Equivalent	Kitazato Biopharma Co., Ltd.
K153478	Sydney IVF Gamete Buffer	Aug 15, 2016	Substantially Equivalent	William A. Cook Australia Pty. , Ltd.
K160863	PBS(-), Phosphate Buffered Saline	Jul 28, 2016	Substantially Equivalent	Kitazato Biopharma Co., Ltd.
K153267	ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash	Jul 22, 2016	Substantially Equivalent	Origio A/S
K152717	Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit	May 06, 2016	Substantially Equivalent	William A. Cook Australia Pty. , Ltd.
K152682	Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit	May 05, 2016	Substantially Equivalent	Willian A. Cook Australia Pty, Ltd.
K160006	Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit	May 04, 2016	Substantially Equivalent	Irvine Scientific
K160814	Sydney IVF Sperm Cryopreservation Buffer	Apr 22, 2016	Substantially Equivalent	William A. Cook Australia Pty. , Ltd.
K160142	MINERAL OIL	Apr 21, 2016	Substantially Equivalent	Kitazato Biopharma Co., Ltd.
K152932	BlastGen	Feb 29, 2016	Substantially Equivalent	Origio A/S
K153290	Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium	Jan 27, 2016	Substantially Equivalent	William A. Cook Australia Pty. , Ltd.
K151367	Sydney IVF Hyaluronidase	Jan 27, 2016	Substantially Equivalent	William A. Cook Australia Pty. , Ltd.
K152782	SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT	Dec 21, 2015	Substantially Equivalent	William A. Cook Australia Pty. , Ltd.
K150950	FreezeKit Cleave , ThawKit Cleave	Dec 21, 2015	Substantially Equivalent	Vitrolife Sweden AB
K152904	SYDNEY IVF EMBRYO BIOPSY MEDIUM	Dec 03, 2015	Substantially Equivalent	William A. Cook Australia Pty. , Ltd.
K152440	Sydney IVF PVP	Sep 23, 2015	Substantially Equivalent	Willam A. Cook Australia Pty, Ltd.
K143724	COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit	Aug 27, 2015	Substantially Equivalent	William A. Cook Australia Pty. , Ltd.
K142991	LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA	Feb 17, 2015	Substantially Equivalent	Life Global Group, LLC
K143498	LifeGlobal Global HP	Jan 20, 2015	Substantially Equivalent	Life Global Group, LLC
K133568	G-TL	Jul 16, 2014	Substantially Equivalent	Vitrolife, Inc.
K140317	EMBRYOGEN	Jun 16, 2014	Substantially Equivalent	Origio A/S
K133912	ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO	May 14, 2014	Substantially Equivalent	Origio A/S
K133387	ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL RED	Apr 29, 2014	Substantially Equivalent	Origio A/S
K133707	SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS	Apr 16, 2014	Substantially Equivalent	Origio A/S
K113786	SPERMFREEZE SOLUTION	Oct 26, 2012	Substantially Equivalent	Vitrolife Sweden AB
K120136	EMBRYOGEN	Sep 26, 2012	Substantially Equivalent	Origio A/S
K121572	CONTINUOUS SINGLE CULTURE COMPLETE	Jul 19, 2012	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K121128	MULTIPURPOSE HANDLING MEDIUM	Jun 06, 2012	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K112083	LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES	May 03, 2012	Substantially Equivalent	<Genx> Intl., Inc.
K092963	GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3	Jan 14, 2011	Substantially Equivalent	Genx Intl., Inc.
K101003	RAPIDVIT BLAST, RAPIDWARM BLAST	Dec 10, 2010	Substantially Equivalent	Vitrolife Sweden AB
K100367	MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229	Aug 27, 2010	Substantially Equivalent	Origio A/S
K092107	VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010	Jun 15, 2010	Substantially Equivalent	Nidacon International AB
K092667	GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT	Jun 03, 2010	Substantially Equivalent	Genx Intl., Inc.
K092578	LIFEGLOBAL PROTEIN SUPPLEMENT	Apr 05, 2010	Substantially Equivalent	Genx Intl., Inc.
K093273	VIT KIT - FREEZE AND THAW	Mar 03, 2010	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K082363	COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000) KITS	Apr 29, 2009	Substantially Equivalent	William A. Cook Australia Pty. , Ltd.
K083509	LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA	Apr 24, 2009	Substantially Equivalent	Genx Intl., Inc.
K080172	BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 1216	Dec 18, 2008	Substantially Equivalent	Medicult A/S
K080446	RAPIDVIT AND RAPIDWARM CLEAVE	Nov 26, 2008	Substantially Equivalent	Vitrolife Sweden AB
K073522	VITRIFICATION KIT & VITRIFICATION WARMING KIT	Oct 10, 2008	Substantially Equivalent	Sage In-Vitro Fertilization, Inc.
K081639	ICSI CUMULASE	Sep 19, 2008	Substantially Equivalent	Medicult A/S
K081115	G-MOPS G5 SERIES	Sep 17, 2008	Substantially Equivalent	Vitrolife Sweden AB
K081117	G-2 V5	Sep 16, 2008	Substantially Equivalent	Vitrolife Sweden AB
K081114	G-1 V5	Sep 16, 2008	Substantially Equivalent	Vitrolife Sweden AB
K080473	EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED	Sep 03, 2008	Substantially Equivalent	Medicult A/S
K081116	G-IVF G5 SERIES	Sep 02, 2008	Substantially Equivalent	Vitrolife Sweden AB
K072609	SINGLE STEP MEDIUM	Feb 12, 2008	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K072608	LYOPHILIZED MULTIBLAST MEDIUM KIT	Jan 30, 2008	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K072607	LYOPHILIZED EARLY CLEAVAGE MEDIUM (ECM) KIT	Jan 25, 2008	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K070135	VITRIFREEZE MEDIUM; VITRITHAW MEDIUM	Aug 16, 2007	Substantially Equivalent	Fertipro NV
K070689	LG SPERM FREEZING	Jul 03, 2007	Substantially Equivalent	Genx Intl., Inc.
K061309	EMBRYOASSIST	Feb 08, 2007	Substantially Equivalent	Medicult A/S
K061145	SPERMSLOW	Oct 02, 2006	Substantially Equivalent	Medicult A/S
K061371	SYDNEY IVF SPERM CRYOPRESERVATION BUFFER	Aug 17, 2006	Substantially Equivalent	Cook Urological, Inc.
K060983	BIOPSY MEDIUM, MODEL REF 1062	Jul 28, 2006	Substantially Equivalent	Medicult A/S
K053646	INVITRO MATURATION MEDIA	Jul 14, 2006	Substantially Equivalent	Sage In-Vitro Fertilization, Inc.
K053552	GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA	May 19, 2006	Substantially Equivalent	<Genx> Intl., Inc.
K060699	SYNVITRO CUMULASE (HYALURONIDASE MEDIUM)	May 10, 2006	Substantially Equivalent	Medicult A/S
K053551	MICROMANIPULATION MEDIA SYSTEM, LG HYALURONIDASE AND LG PARAFFIN OIL	May 09, 2006	Substantially Equivalent	<Genx> Intl., Inc.
K060168	VITRIFICATION FREEZE KIT, VITRIFICATION THAW KIT	Apr 24, 2006	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K053494	OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE	Mar 23, 2006	Substantially Equivalent	Fertipro NV
K042495	CUMULASE	Apr 14, 2005	Substantially Equivalent	Halozyme Therapeutics, Inc.
K043116	ICSI-100	Jan 13, 2005	Substantially Equivalent	Vitrolife Sweden AB
K041284	MEDICULT IVM SYSTEM	Nov 22, 2004	Substantially Equivalent	Medicult A/S
K040530	MEDIA CULTURE SYSTEM	Jun 25, 2004	Substantially Equivalent	<Genx> Intl., Inc.
K033101	G-PGD	May 07, 2004	Substantially Equivalent	Vitrolife Sweden AB
K032877	G-OOCYTE	May 07, 2004	Substantially Equivalent	Vitrolife Sweden AB
K032155	G-THAWKIT BLAST	May 07, 2004	Substantially Equivalent	Vitrolife AB
K032154	G-FREEZEKIT BLAST	May 07, 2004	Substantially Equivalent	Vitrolife AB
K034063	MULTIBLAST MEDIUM	Apr 26, 2004	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K031304	SYDNEY IVF PVP	Mar 23, 2004	Substantially Equivalent	Cook Urological, Inc.
K033462	EARLY CLEAVAGE MEDIUM (ECM)	Jan 15, 2004	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K032887	PHENOL RED STOCK SOLUTION	Dec 19, 2003	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K030441	SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT	Aug 29, 2003	Substantially Equivalent	Cook Ob/Gyn
K030490	ISM1+, IMS2+, AND UTM+	Aug 20, 2003	Substantially Equivalent	Medicult A/S
K031486	BLASTFREEZE AND BLASTTHAW	Jun 27, 2003	Substantially Equivalent	Medicult A/S
K031228	SYNVITRO HYADASE	Jun 24, 2003	Substantially Equivalent	Medicult A/S
K031015	EMBRYOGLUE	Jun 23, 2003	Substantially Equivalent	Vitrolife Sweden AB
K030850	ENHANCE HUMAN SERUM ALBUMIN	Apr 08, 2003	Substantially Equivalent	Conception Technologies
K030117	ENHANCE SPERM FREEZE	Mar 20, 2003	Substantially Equivalent	Conception Technology, Inc.
K024290	PROMOTOR FINAL RINSE SPERM WASH MEDIUM	Mar 03, 2003	Substantially Equivalent	Ceres Fertility, Inc.
K030116	ENHANCE-S PLUS H	Feb 12, 2003	Substantially Equivalent	Conception Technology, Inc.
K023850	SYDNEY IVF EMBRYO BIOPSY MEDIUM	Jan 22, 2003	Substantially Equivalent	Cook Ob/Gyn
K023222	ISOCARE ONE STEP SPERM PROCESSING MEDIUM CAT# 2207-12	Dec 26, 2002	Substantially Equivalent	Invitrocare, Inc.
K023353	SYDNEY IVF HYALURONIDASE	Dec 20, 2002	Substantially Equivalent	Cook Urological, Inc.
K023717	SPERM WASH MEDIUM WITH GENTAMICIN	Dec 13, 2002	Substantially Equivalent	Conception Technologies
K023655	ENHANCE HTF MEDIUM WITH HEPES	Dec 13, 2002	Substantially Equivalent	Conception Technologies
K023403	SPERMGRAD, MODELS 10022/10063	Dec 13, 2002	Substantially Equivalent	Vitrolife Sweden AB
K023033	ALLGRAD WASH (HERPES BUFFERED WASHING MEDIUM)	Nov 26, 2002	Substantially Equivalent	<Genx> Intl., Inc.
K023206	SPERM CRYOPROTEC	Nov 08, 2002	Substantially Equivalent	Nidacon International AB
K023106	PROMOTOR	Nov 05, 2002	Substantially Equivalent	Ceres Fertility, Inc.
K022931	HYALURONIDASE SOLUTION	Nov 04, 2002	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K022295	G-RINSE, MODEL 10031	Sep 12, 2002	Substantially Equivalent	Vitrolife Sweden AB
K022247	G-SPERM, MODEL 10032	Sep 06, 2002	Substantially Equivalent	Vitrolife Sweden AB
K022245	G-FERT, MODEL 10033	Sep 06, 2002	Substantially Equivalent	Vitrolife Sweden AB
K022244	G-1 VERSION 3, MODEL 10048	Sep 06, 2002	Substantially Equivalent	Vitrolife Sweden AB
K021896	HSA-SOLUTION, MODEL 10034/10064	Sep 06, 2002	Substantially Equivalent	Vitrolife Sweden AB
K021894	G-MM, MODEL 10038	Sep 06, 2002	Substantially Equivalent	Vitrolife Sweden AB
K021893	G-MOPS, MODEL 10030	Sep 06, 2002	Substantially Equivalent	Vitrolife Sweden AB
K021890	G-2 VERSION 3, MODEL 10049	Sep 06, 2002	Substantially Equivalent	Vitrolife Sweden AB
K022590	PVP (POLYVINYLPYRROLIDONE)	Aug 30, 2002	Substantially Equivalent	<Genx> Intl., Inc.
K022547	ACIDIFIED TYRODES SOLUTION	Aug 28, 2002	Substantially Equivalent	<Genx> Intl., Inc.
K022443	SPERMASSIST	Aug 28, 2002	Substantially Equivalent	Nidacon International AB
K022352	HTF PLUS WITH HEPES (HTF WITH NON-ESSENTIAL AMINO ACIDS)	Aug 28, 2002	Substantially Equivalent	<Genx> Intl., Inc.
K022334	HTF PLUS - HTF WITH NON-ESSENTIAL AMINO ACIDS	Aug 28, 2002	Substantially Equivalent	<Genx> Intl., Inc.
K022330	ALLGRAD 45 AND 90 CELL SEPARATION MEDIA	Aug 26, 2002	Substantially Equivalent	<Genx> Intl., Inc.
K022335	ALLGRAD AND ALLGRAD100	Aug 23, 2002	Substantially Equivalent	<Genx> Intl., Inc.
K022332	LITE MINERAL OIL	Aug 23, 2002	Substantially Equivalent	<Genx> Intl., Inc.
K022002	SYDNEY IVF CULTURE OIL	Aug 12, 2002	Substantially Equivalent	Cook Urological, Inc.
K021358	EMBRYO BIOPSY MEDIUM	Jul 05, 2002	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K020490	PBS, PBSW WITH CATIONS AND PHENOL RED	Mar 28, 2002	Substantially Equivalent	Conception Technologies
K013518	EMBRYO FREEZE MEDIUM, EMBRYO THAW MEDIUM	Jan 18, 2002	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K011607	SPERMCATCH	Aug 10, 2001	Substantially Equivalent	Nidacon International AB
K012123	NIDOIL	Aug 03, 2001	Substantially Equivalent	Nidacon International AB
K011938	OIL FOR EMBRYO CULTURE	Jul 18, 2001	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K011606	PURESPERM BUFFER	Jul 12, 2001	Substantially Equivalent	Nidacon International AB
K011573	HYALURONIDASE IN HTF MEDIUM; HYALURONIDASE IN EBSS MEDIUM	Jul 02, 2001	Substantially Equivalent	Conception Technologies
K011481	10% PVP; 10% PVP IN EBSS SOLUTION	Jul 02, 2001	Substantially Equivalent	Conception Technologies
K011346	READYSWIM	Jun 28, 2001	Substantially Equivalent	Nidacon International AB
K011462	OIL FOR TISSUE CULTURE	Jun 13, 2001	Substantially Equivalent	Conception Technologies
K011157	COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT	May 03, 2001	Substantially Equivalent	Cook Urological, Inc.
K010183	GLOBAL BY <GENX> BLASTOCYST MEDIA	May 02, 2001	Substantially Equivalent	<Genx> Intl., Inc.
K003404	SUPRASPERM SYSTEM	Mar 22, 2001	Substantially Equivalent	Medicult A/S
K003163	SYNVITRO FLUSH	Mar 22, 2001	Substantially Equivalent	Medicult A/S
K003156	BLASTASSIST SYSTEM	Mar 22, 2001	Substantially Equivalent	Medicult A/S
K003751	HYALURONIDASE REAGENT, MODEL CAT#2212	Jan 17, 2001	Substantially Equivalent	Invitrocare, Inc.
K003278	COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPLEMENT, MODEL 9922	Jan 17, 2001	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K003734	SERUM PROTEIN SUBSTITUTE	Dec 21, 2000	Substantially Equivalent	Sage Biopharma
K003448	DEXTRAN SERUM SUPPLEMENT (DSS), MODEL 9301	Dec 07, 2000	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K002630	PURESPERM WASH	Nov 21, 2000	Substantially Equivalent	Nidacon International AB
K002623	PURESPERM 40 AND PURESPERM 80	Nov 20, 2000	Substantially Equivalent	Nidacon International AB
K002836	MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE	Oct 03, 2000	Substantially Equivalent	Sage Biopharma
K002385	COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM,	Sep 18, 2000	Substantially Equivalent	Cook Ob/Gyn
K002383	COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT	Sep 13, 2000	Substantially Equivalent	Cook Ob/Gyn
K001967	PVP-POLYVINYLPYRROLIDONE REAGENT, MODEL CAT#2210	Aug 14, 2000	Substantially Equivalent	Invitrocare, Inc.
K991279	MEDI-CULT UNIVERSAL IVF-MEDIUM	Jul 20, 2000	Substantially Equivalent	Medicult A/S
K000619	SCANDINAVIAN IVF SCIENCES AB, G2.2	Jun 27, 2000	Substantially Equivalent	Vitrolife AB/Scandinavian Ivf Sciences AB
K991334	MEDI-CULT HYALURONIDASE;	Jun 20, 2000	Substantially Equivalent	Medicult A/S
K991331	MEDI-CULT M3 MEDIUM	Jun 20, 2000	Substantially Equivalent	Medicult A/S
K001113	IVC THREE BLASTOCYST MEDIUM, CAT # 2007	Jun 13, 2000	Substantially Equivalent	Invitrocare, Inc.
K000627	SCANDINAVIAN IVF SCIENCES AB, HYBASE-1	Jun 13, 2000	Substantially Equivalent	Vitrolife AB/Scandinavian Ivf Sciences AB
K000989	SPERM WASH MEDIUM, CAT# 2003/2005	Jun 08, 2000	Substantially Equivalent	Invitrocare, Inc.
K993484	Q-HTF, CAT# 2001	May 25, 2000	Substantially Equivalent	Invitrocare, Inc.
K000938	IVC ONE MEDIUM	May 25, 2000	Substantially Equivalent	Invitrocare, Inc.
K000937	IVC TWO MEDIUM	May 25, 2000	Substantially Equivalent	Invitrocare, Inc.
K000626	SCANDINAVIAN IVF SCIENCES AB, GAMETE-100	May 23, 2000	Substantially Equivalent	Vitrolife AB/Scandinavian Ivf Sciences AB
K000625	SCANDINAVIAN IVF SCIENCES AB, G1.2	May 23, 2000	Substantially Equivalent	Vitrolife AB/Scandinavian Ivf Sciences AB
K991348	IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2004, 2501, 2500	May 17, 2000	Substantially Equivalent	Vitrolife Sweden AB
K000618	SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 1	May 17, 2000	Substantially Equivalent	Vitrolife AB/Scandinavian Ivf Sciences AB
K000623	SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1	May 16, 2000	Substantially Equivalent	Vitrolife AB/Scandinavian Ivf Sciences AB
K000621	SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100	May 16, 2000	Substantially Equivalent	Vitrolife AB/Scandinavian Ivf Sciences AB
K991472	MEDI-CULT EMBRYO FREEZING MEDIUM INTERNAL CATAGLOG NUMBERS 1079	May 09, 2000	Substantially Equivalent	Medicult A/S
K991471	MEDI-CULT BLASTOCYST FREEZING & THAWING PACKS, INTERNAL CATALOG NUMBERS (1012, 1015)	May 09, 2000	Substantially Equivalent	Medicult A/S
K991332	MEDI-CULT SPERM PREPARATION - MEDIUM;	May 04, 2000	Substantially Equivalent	Medicult A/S
K991327	MEDI-CULT FLUSHING MEDIUM	May 04, 2000	Substantially Equivalent	Medicult A/S
K000940	HUMAN SERUM ALBUMIN (HSA)	May 04, 2000	Substantially Equivalent	Invitrocare, Inc.
K000939	HTF-HEPES	May 04, 2000	Substantially Equivalent	Invitrocare, Inc.
K991380	OIL FOR TISSUE CULTURE	Apr 19, 2000	Substantially Equivalent	Advanced Reproductive Technologies
K000309	BLASTOCYST FREEZE MEDIUM, BLASTOCYST THAW MEDIUM	Mar 13, 2000	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K991470	MEDI-CULT ACIDIFIED TYRODES SOLUTION- MEDIUM; INTERNAL CATALOG NUMBERS (1060)	Mar 07, 2000	Substantially Equivalent	Medicult A/S
K991335	MEDI-CULT FREEZING & THAWING PACKS	Feb 28, 2000	Substantially Equivalent	Medicult A/S
K991333	MEDI-CULT SPERM FREEZE MEDIUM	Feb 28, 2000	Substantially Equivalent	Medicult A/S
K991351	OVOIL-150, MODEL 5002	Feb 25, 2000	Substantially Equivalent	Vitrolife Sweden AB
K991330	MEDI-CULT LIQUID PARAFFIN	Feb 25, 2000	Substantially Equivalent	Medicult A/S
K991329	MEDI-CULT PVP MEDIUM, MEDI-CULT PVP CLINICAL GRADE	Feb 25, 2000	Substantially Equivalent	Medicult A/S
K991346	PH-100, MODEL 2104	Feb 24, 2000	Substantially Equivalent	Vitrolife Sweden AB
K991345	ASP-100, MODEL 2100	Feb 18, 2000	Substantially Equivalent	Vitrolife Sweden AB
K991396	WATER FOR TISSUE CULTURE, MODELS 500 L & 1.5 L	Feb 15, 2000	Substantially Equivalent	Sage Biopharma
K991395	QUINN'S HTF MEDIUM, QUINN'S HTF MEDIUM WITH HEPES, QUINN'S BASAL XI HTF MEDIUM, QUINN'S D3+ HTF MEDIUM	Feb 15, 2000	Substantially Equivalent	Advanced Reproductive Technologies
K991392	HUMAN SERUM ALBUMIN	Feb 07, 2000	Substantially Equivalent	Advanced Reproductive Technologies
K991393	HYALURONIDASE, 80 U/ML	Feb 02, 2000	Substantially Equivalent	Sage Biopharma
K991379	QUINN'S SPERM WASHING MEDIUM	Feb 02, 2000	Substantially Equivalent	Advanced Reproductive Technologies
K991390	1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING MEDIUM, 9% GLYCEROL, 0.2 M SUCROSE FREEZING MEDI	Jan 18, 2000	Substantially Equivalent	Sage Biopharma
K991391	PVP, POLYVINYLPYRROLIDONE 10% (W/V) IN HEPES-HTF	Jan 10, 2000	Substantially Equivalent	Advanced Reproductive Technologies
K991339	TYRODE'S SOLUTION-ACIDIFIED	Dec 06, 1999	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K991381	PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA	Sep 24, 1999	Substantially Equivalent	Pacific Andrology, Inc.
K991378	PHOSPHATE BUFFERED SALINE (PBS), PHOSPHATE BUFFERED SALINE WITH CALCIUM, MAGNESIUM, GLUCOSE, PYRUVATE AND PHENOL RED	Sep 24, 1999	Substantially Equivalent	Sage Biopharma
K991419	MODIFIED HAM'S F-10 BASAL MEDIUM, MODIFIED HAMS'S F-10 BASAL MEDIUM HEPES, MODIFIED HAM'S F-10 SUPPLEMENT (50X) IYOPHILI	Sep 14, 1999	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K991022	<GENX> SPERM WASHING MEDIA	Sep 09, 1999	Substantially Equivalent	<Genx> Intl., Inc.
K991322	ENHANCE-S PLUS	Jul 26, 1999	Substantially Equivalent	Conception Technology, Inc.
K991173	<GENX> FERTILIZATION MEDIA-HTF	Jul 19, 1999	Substantially Equivalent	<Genx> Intl., Inc.
K991343	PVP (POLYVINYLPYRROLIDONE)	Jul 14, 1999	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K991338	BOVINE SERUM ALBUMIN (BSA)	Jul 14, 1999	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K991342	PBS 1X- DULBECCO'S PHOSPHATE BUFFERED SALINE SOLUTION	Jul 08, 1999	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K991341	ISOLATE, ISOLATE CONCENTRATE, ISOLATE STOCK SOLUTION	Jul 08, 1999	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K991337	SPERM MAINTENANCE MEDIUM WITH GLYCEROL	Jul 08, 1999	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K991421	FREEZING MEDIUM - TEST YOLK BUFFER (TYB) WITH GLYCEROL, REFRIGERATION MEDIUM - TEST YOLK BUFFER 9TYB)	Jul 02, 1999	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K991420	MODIFIED HAM'S F-10 WITH ALBUMIN	Jul 02, 1999	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K983588	SPERM WASHING MEDIUM, MODIFIED SPERM WASHING MEDIUM	Apr 26, 1999	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K983579	SYNTHETIC SERUM SUBSTITUTE (SSS)	Apr 23, 1999	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K983589	P-1 (PREIMPLANTATION STAGE ONE) MEDIUM	Feb 18, 1999	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K983586	HTF MEDIUM, MODIFIED HTF MEDIUM- HEPES, HTF POWDER (WITHOUT ANTIBIOTICS), MODIFIED HTG POWDER- HEPES (WITHOUT ANTIBODITI	Feb 18, 1999	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K983580	BLASTOCYST MEDIUM	Feb 18, 1999	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K983584	HUMAN SERUM ALBUMIN (HSA)	Feb 08, 1999	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K984172	MODIFICATION OF PURESPERM	Jan 14, 1999	Substantially Equivalent	Nidacon International AB
K980814	PURESPERM	Jun 23, 1998	Substantially Equivalent	Nidacon International AB
K971809	ISOLATE	Jul 03, 1997	Substantially Equivalent	Irvine Scientific Sales Co., Inc.
K864524	SPERM SELECT(TM)	Feb 02, 1987	Substantially Equivalent	Pharmacia, Inc.