VERIFY Assert Self-Contained Biological Indicator
FDA 510(k) clearance K200126 · decided 2020-05-22
Clearance details
- K-number
- K200126
- Device name
- VERIFY Assert Self-Contained Biological Indicator
- Applicant
- STERIS Corporation
- Decision
- Substantially Equivalent
- Date received
- 2020-01-21
- Decision date
- 2020-05-22
- Days to decision
- 122 days
- Clearance type
- Traditional
- Product code
- FRC
- Device class
- 2
- Regulation number
- 880.2800
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mentor, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.