1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING MEDIUM, 9% GLYCEROL, 0.2 M SUCROSE FREEZING MEDI— 510(k) K991390
Substantially EquivalentSage Biopharma
FDA 510(k) clearance K991390 for 1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING MEDIUM, 9% GLYCEROL, 0.2 M SUCROSE FREEZING MEDI, Substantially Equivalent on 2000-01-18. Applicant: Sage Biopharma. Device class: 2.
Clearance details
- Applicant
- Sage Biopharma
- Product code
- Code MQL
- Device class
- Class 2
- Regulation
- 21 CFR 884.6180
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code MQL
view allMore clearances from Sage Biopharma
view all- K003734 — SERUM PROTEIN SUBSTITUTE
- K002836 — MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE
- K991396 — WATER FOR TISSUE CULTURE, MODELS 500 L & 1.5 L
- K991393 — HYALURONIDASE, 80 U/ML
- K991378 — PHOSPHATE BUFFERED SALINE (PBS), PHOSPHATE BUFFERED SALINE WITH CALCIUM, MAGNESIUM, GLUCOSE, PYRUVATE AND PHENOL RED
Recalls naming K991390
K-number listed on FDA's recall record- Z-2850-2016 — Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number: ART -8017 SAGE In Vitro Fertilization, Inc. A CooperSurgical Company 95 Corporate Drive Trumbull, CT 06611 USA
- Z-2851-2016 — Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium Product Number: ART-8018 Intended for use in freezing embryos. This product is intended for thawing of embryos frozen with ART-8017, CSC Freezing Medium. This kit is designed to be used in conjunction with the SAGE CSC Freezing Medium Kit (ART-8017).
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K991390.
Data sourced from openFDA. This site is unofficial and independent of the FDA.