ALLGRAD 45 AND 90 CELL SEPARATION MEDIA— 510(k) K022330
Substantially Equivalent<Genx> Intl., Inc.
FDA 510(k) clearance K022330 for ALLGRAD 45 AND 90 CELL SEPARATION MEDIA, Substantially Equivalent on 2002-08-26. 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
- Guilford, CT, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.