PICSI SPERM SELECTION DEVICE— 510(k) K052457
Substantially EquivalentBiocoat, Inc.
FDA 510(k) clearance K052457 for PICSI SPERM SELECTION DEVICE, Substantially Equivalent on 2006-04-13. Applicant: Biocoat, Inc.. Device class: 2.
Clearance details
- Applicant
- Biocoat, Inc.
- Product code
- Code MQK
- Device class
- Class 2
- Regulation
- 21 CFR 884.6160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Horsham, PA, US
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More clearances from Biocoat, Inc.
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