Liquid Chemical Processing System
The Liquid Chemical Processing System is a general hospital device intended as a standard method for routine monitoring, used to process and assess chemical sterilization procedures. It is classified as Class 2 (FDA Class 2), which requires 510(k) premarket notification to demonstrate substantial equivalence to a predicate device. The product code is OVY and the applicable regulation number is 880.6887, falling under the General Hospital medical specialty.
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Basic Information
- Product Code
- OVY
- Device Class
- FDA class 2
- Regulation Number
- 880.6887
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
Definition
The liquid chemical processing system is intended as a standard method for routine monitoring.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K233682 | VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE | Dec 15, 2023 | Substantially Equivalent | STERIS Corporation |
| K231746 | VERIFY Spore Test Strip for S40 Sterilant Concentrate | Sep 11, 2023 | Substantially Equivalent | STERIS Corporation |
| K180553 | VERIFY Spore Test Strip for S40 Sterilant | May 29, 2018 | Substantially Equivalent | STERIS Corporation |
| DEN110002 | SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT | Mar 30, 2012 | Unknown | STERIS Corporation |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.