Phenol Red Stock Solution
FDA 510(k) K032887 · Irvine Scientific Sales Co., Inc.
510(k) numberK032887
Submission
- Device name
- Phenol Red Stock Solution
- Applicant
- Irvine Scientific Sales Co., Inc.
Santa Ana, CA, US - Received
- September 16, 2003
- Decision date
- December 19, 2003
- 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 |
|---|---|---|
| K171224 | Arctic Sperm Cryopreservation MediumMQL · Traditional | 08/31/2017SE |
| K170681 | Continuous Single Culture -NX (CSCM-NX)MQL · Traditional | 06/08/2017SE |
| K170602 | Continuous Single Culture-NX Complete (CSCM-NXC)MQL · Traditional | 06/07/2017SE |
| K121572 | Continuous Single Culture CompleteMQL · Traditional | 07/19/2012SE |
| K121128 | Multipurpose Handling MediumMQL · Traditional | 06/06/2012SE |
| K093273 | Vit Kit - Freeze and ThawMQL · Traditional | 03/03/2010SE |
| K072609 | Single Step MediumMQL · Traditional | 02/12/2008SE |
| K072608 | Lyophilized Multiblast Medium KitMQL · Traditional | 01/30/2008SE |
| K072607 | Lyophilized Early Cleavage Medium (Ecm) KitMQL · Traditional | 01/25/2008SE |
| K061549 | Amniostat-Flm-PgJHG · Traditional | 10/18/2006SE |
Questions and answers
When was Phenol Red Stock Solution cleared by the FDA?
Phenol Red Stock Solution (K032887) received a 510(k) decision of Substantially Equivalent on December 19, 2003, 94 days after the submission was received.
What is the product code of K032887?
The FDA product code is MQL – Media, Reproductive, a Class II (moderate risk) device regulated under 21 CFR 884.6180.