BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B— 510(k) K012811
Substantially EquivalentHumagen Fertility Diagnostics, Inc.
FDA 510(k) clearance K012811 for BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B, Substantially Equivalent on 2002-02-11. Applicant: Humagen Fertility Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Humagen Fertility Diagnostics, Inc.
- Product code
- Code MQH
- Device class
- Class 2
- Regulation
- 21 CFR 884.6130
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Charlottesville, VA, US
Recent devices under product code MQH
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Data sourced from openFDA. This site is unofficial and independent of the FDA.