SMART-READ EZTEST-STEAM SCBI AND TEST PACK
FDA 510(k) clearance K093794 · decided 2010-05-14
Clearance details
- K-number
- K093794
- Device name
- SMART-READ EZTEST-STEAM SCBI AND TEST PACK
- Applicant
- Sgm Biotech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-12-10
- Decision date
- 2010-05-14
- Days to decision
- 155 days
- Clearance type
- Special
- Product code
- FRC
- Device class
- 2
- Regulation number
- 880.2800
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Bozeman, MT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61 recall (Z-1994-2013) | Getinge USA Inc | 2013-08-21 |
| Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determi recall (Z-1868-2013) | Mesa Laboratories, Inc., Bozeman Manufacturing Facility | 2013-08-01 |