MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE— 510(k) K002836
Substantially EquivalentSage Biopharma
FDA 510(k) clearance K002836 for MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE, Substantially Equivalent on 2000-10-03. 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
- Special
- Location
- Irvine, CA, US
Recent devices under product code MQL
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- K991378 — PHOSPHATE BUFFERED SALINE (PBS), PHOSPHATE BUFFERED SALINE WITH CALCIUM, MAGNESIUM, GLUCOSE, PYRUVATE AND PHENOL RED
Data sourced from openFDA. This site is unofficial and independent of the FDA.