BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540— 510(k) K022643
Substantially EquivalentSwemed Lab International AB
FDA 510(k) clearance K022643 for BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540, Substantially Equivalent on 2002-11-05. Applicant: Swemed Lab International AB. Device class: 2.
Clearance details
- Applicant
- Swemed Lab International AB
- 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
- Washington, DC, US
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