ASSERT EO BIOLOGICAL TEST PACK
FDA 510(k) clearance K854631 · decided 1986-05-27
Clearance details
- K-number
- K854631
- Device name
- ASSERT EO BIOLOGICAL TEST PACK
- Applicant
- Surgicot, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-11-18
- Decision date
- 1986-05-27
- Days to decision
- 190 days
- Clearance type
- Traditional
- Product code
- FRC
- Device class
- 2
- Regulation number
- 880.2800
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Smithtown, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VERIFY Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation recall (Z-0605-2014) | Steris Corporation | 2013-12-28 |