Embryoassist and Embryoassist with Phenol Red
FDA 510(k) K080473 · Medicult A/S
510(k) numberK080473
Submission
- Device name
- Embryoassist and Embryoassist with Phenol Red
- Applicant
- Medicult A/S
San Diego, CA, US - Received
- February 21, 2008
- Decision date
- September 3, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K080172 | Blastassist Without Phenol Red, Model Ref 1215, Blastassist with Phenol Red, Model Ref…MQL · Traditional | 12/18/2008SE |
| K081639 | Icsi CumulaseMQL · Traditional | 09/19/2008SE |
| K061309 | EmbryoassistMQL · Traditional | 02/08/2007SE |
| K061145 | SpermslowMQL · Traditional | 10/02/2006SE |
| K060983 | Biopsy Medium, Model Ref 1062MQL · Traditional | 07/28/2006SE |
| K060699 | Synvitro Cumulase (Hyaluronidase Medium)MQL · Traditional | 05/10/2006SE |
| K041284 | Medicult Ivm SystemMQL · Traditional | 11/22/2004SE |
| K030490 | ISM1+, IMS2+, and Utm+MQL · Traditional | 08/20/2003SE |
| K031486 | Blastfreeze and BlastthawMQL · Traditional | 06/27/2003SE |
| K031228 | Synvitro HyadaseMQL · Traditional | 06/24/2003SE |
Questions and answers
When was Embryoassist and Embryoassist with Phenol Red cleared by the FDA?
Embryoassist and Embryoassist with Phenol Red (K080473) received a 510(k) decision of Substantially Equivalent on September 3, 2008, 195 days after the submission was received.
What is the product code of K080473?
The FDA product code is MQL – Media, Reproductive, a Class II (moderate risk) device regulated under 21 CFR 884.6180.