FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERIFY Spore Test Strip for S40 Sterilant Concentrate
K Number: K231746
·
Decision Sep 11, 2023
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
3
Applicant Total
204
Review Days
88
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Basic Information
- Device Name
- VERIFY Spore Test Strip for S40 Sterilant Concentrate
- K Number
- K231746
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6887
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- STERIS Corporation
- Date Received
- June 15, 2023
- Decision Date
- September 11, 2023
- Product Code
- OVY
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OVY | Liquid Chemical Processing System | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OVY), ordered by most recent decision date.
VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE
FDA 510(k)
FDA Class 2
·General Hospital
VERIFY Spore Test Strip for S40 Sterilant
FDA 510(k)
FDA Class 2
·General Hospital
SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT
FDA 510(k)
FDA Class 2
·General Hospital
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