COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit
FDA 510(k) K143724 · William A. Cook Australia Pty. , Ltd.
510(k) numberK143724
Submission
- Device name
- COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit
- Applicant
- William A. Cook Australia Pty. , Ltd.
Brisbane, AU - Received
- December 29, 2014
- Decision date
- August 27, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQL – Media, Reproductive
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.6180
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code MQL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254261 | Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)MQL · Traditional | Cell Store (Beijing) Biotechnology Co., Ltd. | 08/28/2026SE |
| K260248 | Ultra-Fast WarmMQL · Traditional | Kitazato Corporation | 04/28/2026SE |
| K252672 | CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5)MQL · Traditional | Casebioscience, Inc. | 02/20/2026SE |
| K250445 | Fast Warm - NXMQL · Traditional | Fujifilm Irvine Scientific | 09/12/2025SE |
| K251637 | Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle…MQL · Traditional | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 08/27/2025SE |
| K251305 | Ultra-Fast Vitri; Ultra-Fast WarmMQL · Traditional | Kitazato Corporation | 08/26/2025SE |
| K242640 | FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicinMQL · Traditional | Fertipro NV | 05/30/2025SE |
| K242561 | Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)MQL · Traditional | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 04/10/2025SE |
| K242089 | Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)MQL · Traditional | Jiangsu Ruifuda Medical Device Co., Ltd. | 04/10/2025SE |
| K242107 | CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); CaseBioscience® HTF (HTFC)…MQL · Traditional | Casebioscience, Inc. | 03/21/2025SE |
More from Casebioscience, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K173431 | Towako Transmyometrial Embryo Transfer SetMQF · Special | 05/18/2018SE |
| K171611 | Double Lumen Ovum Aspiration NeedlesMQE · Special | 12/15/2017SE |
| K160753 | COOK Vacuum PumpMQG · Traditional | 06/13/2017SE |
| K170257 | Sydney IVF Culture OilMQL · Special | 02/24/2017SE |
| K153478 | Sydney IVF Gamete BufferMQL · Traditional | 08/15/2016SE |
| K152717 | Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing KitMQL · Special | 05/06/2016SE |
| K160814 | Sydney IVF Sperm Cryopreservation BufferMQL · Special | 04/22/2016SE |
| K153290 | Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage…MQL · Special | 01/27/2016SE |
| K151367 | Sydney IVF HyaluronidaseMQL · Traditional | 01/27/2016SE |
| K152782 | Sydney Ivf Sperm Medium, Sydney Ivf Sperm Gradient Kit, Sydney Ivf SpermientMQL · Special | 12/21/2015SE |
Questions and answers
When was COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit cleared by the FDA?
COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit (K143724) received a 510(k) decision of Substantially Equivalent on August 27, 2015, 241 days after the submission was received.
What is the product code of K143724?
The FDA product code is MQL – Media, Reproductive, a Class II (moderate risk) device regulated under 21 CFR 884.6180.