EZTEST
FDA 510(k) clearance K963841 · decided 1997-02-25
Clearance details
- K-number
- K963841
- Device name
- EZTEST
- Applicant
- Sgm Biotech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-09-25
- Decision date
- 1997-02-25
- Days to decision
- 153 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 |