SMART-WELL EZTEST INCUBATOR— 510(k) K091950
Substantially EquivalentSgm Biotech, Inc.
FDA 510(k) clearance K091950 for SMART-WELL EZTEST INCUBATOR, Substantially Equivalent on 2010-01-15. Applicant: Sgm Biotech, Inc.. Device class: 2.
Clearance details
- Applicant
- Sgm Biotech, Inc.
- Product code
- Code FRC
- Device class
- Class 2
- Regulation
- 21 CFR 880.2800
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bozeman, MT, US
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