EZTEST-STEAM
FDA 510(k) clearance K930682 · decided 1994-04-04
Clearance details
- K-number
- K930682
- Device name
- EZTEST-STEAM
- Applicant
- Sgm Biotech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-02-10
- Decision date
- 1994-04-04
- Days to decision
- 418 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the ef recall (Z-1867-2013) | Mesa Laboratories, Inc., Bozeman Manufacturing Facility | 2013-08-01 |
| Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributor Product Cod recall (Z-1822-2013) | Steritec Products Mfc. Co., Inc. | 2013-07-29 |
| Cardinal Steam Biological Indicator, SteriTec Product Code PL 218, Distributor Product Cod recall (Z-1823-2013) | Steritec Products Mfc. Co., Inc. | 2013-07-29 |
| EZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400 EZTest Steam Biol recall (Z-1824-2013) | Steritec Products Mfc. Co., Inc. | 2013-07-29 |