VERIFY SCBI 275F 3-10
FDA 510(k) clearance K083665 · decided 2009-09-01
Clearance details
- K-number
- K083665
- Device name
- VERIFY SCBI 275F 3-10
- Applicant
- STERIS Corporation
- Decision
- Substantially Equivalent
- Date received
- 2008-12-10
- Decision date
- 2009-09-01
- Days to decision
- 265 days
- Clearance type
- Abbreviated
- 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
| Record | Firm | Date |
|---|---|---|
| VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Number: S3060 In recall (Z-0778-2023) | Steris Corporation | 2023-01-03 |
| VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number: S3061 I recall (Z-0779-2023) | Steris Corporation | 2023-01-03 |
| VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in in recall (Z-0780-2023) | Steris Corporation | 2023-01-03 |
| VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in i recall (Z-0781-2023) | Steris Corporation | 2023-01-03 |
| VERIFY Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation recall (Z-0605-2014) | Steris Corporation | 2013-12-28 |