1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING MEDIUM, 9% GLYCEROL, 0.2 M SUCROSE FREEZING MEDI
FDA 510(k) clearance K991390 · decided 2000-01-18
Clearance details
- K-number
- K991390
- Device name
- 1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING MEDIUM, 9% GLYCEROL, 0.2 M SUCROSE FREEZING MEDI
- Applicant
- Sage Biopharma
- Decision
- Substantially Equivalent
- Date received
- 1999-04-21
- Decision date
- 2000-01-18
- Days to decision
- 272 days
- Clearance type
- Traditional
- Product code
- MQL
- Device class
- 2
- Regulation number
- 884.6180
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . recall (Z-2850-2016) | CooperSurgical, Inc. | 2016-09-20 |
| Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium Pro recall (Z-2851-2016) | CooperSurgical, Inc. | 2016-09-20 |