GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3— 510(k) K092963
Substantially EquivalentGenx Intl., Inc.
FDA 510(k) clearance K092963 for GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3, Substantially Equivalent on 2011-01-14. 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
Recent devices under product code MQL
view allMore clearances from Genx Intl., Inc.
view allRecalls naming K092963
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K092963.
Data sourced from openFDA. This site is unofficial and independent of the FDA.