Identifiers
- 510(k) Number
- K202565 FDA 510(k)
- FDA Product Code
- JOJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.2800 FDA 510(k)
- Regulation Number
- 880.2800 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The WAVICIDE-OPA MEC Indicator is a medical device classified under the product code JOJ for physical/chemical sterilization processes. It is designed to monitor and indicate the effectiveness of sterilization cycles, specifically for ortho-phthalaldehyde (OPA) and multi-enzymatic cleaner (MEC) solutions. The device functions as a chemical indicator to verify exposure to sterilizing agents during processing.
This device is intended for use in general hospital settings and is regulated under 21 CFR 880.2800. It is supplied non-sterile and is for single-use only. The device received FDA 510(k) clearance under number K202565 on December 2, 2020, and is manufactured by Serim Research Corporation in Elkhart, Indiana, United States.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: WAVICIDE-OPA MEC Indicator by Serim Research Corporation | FDA 510(k ..., K202565 - WAVICIDE-OPA MEC Indicator - General Hospital, WAVICIDE-OPA MEC Indicator - FDA 510(k) K202565, WAVICIDE-OPA MEC Indicator (K202565) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202565 | Class II | Active |
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Manufacturer
- Manufacturer
- Serim Research Corporation
Sources (1)
- FDA 510(k) K202565 24 fields · synced Sep 21, 2026