CELERITY HP Chemical Indicator
FDA 510(k) clearance K213262 · decided 2022-01-07
Clearance details
- K-number
- K213262
- Device name
- CELERITY HP Chemical Indicator
- Applicant
- STERIS Corporation
- Decision
- Substantially Equivalent
- Date received
- 2021-09-30
- Decision date
- 2022-01-07
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- QKM
- 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.