GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT— 510(k) K092667
Substantially EquivalentGenx Intl., Inc.
FDA 510(k) clearance K092667 for GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT, Substantially Equivalent on 2010-06-03. Applicant: Genx Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Genx Intl., Inc.
- 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
- Gilford, CT, US
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