Sterrad Chemical Indicator Strip
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K103218 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 Sterrad Chemical Indicator Strip is a device designed to monitor the presence or attainment of one or more parameters required for a satisfactory sterilization process. It is used to verify that critical parameters such as temperature, time, or sterilant have been met during the sterilization cycle.
This single-use chemical indicator strip is supplied in cases of 1000 units and is intended for use with STERRAD Sterilization Systems. The strip provides an easy-to-read visual indication from unprocessed to processed loads. The device is classified under product code JOJ and has FDA 510K clearance.
Frequently asked questions
What is the Sterrad Chemical Indicator Strip used for?
The Sterrad Chemical Indicator Strip is designed to monitor the presence or attainment of critical parameters required for a satisfactory sterilization process. It verifies that temperature, time, or sterilant have been met during the sterilization cycle.
How is the Sterrad Chemical Indicator Strip supplied?
This single-use chemical indicator strip is supplied in cases of 1000 units and is specifically intended for use with STERRAD Sterilization Systems.
How does the indicator strip show sterilization results?
The strip provides an easy-to-read visual indication that changes from unprocessed to processed loads, allowing users to quickly verify that the sterilization cycle has been completed successfully.
What is the regulatory classification of this device?
The Sterrad Chemical Indicator Strip is classified under product code JOJ and has FDA 510K clearance, indicating it has been determined to be substantially equivalent to predicate devices.
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: Chemical Indicator Strips | ASP, ASP® Sterrad® Sterilization Chemical Indicator Strip - Medical Supply HQ, Chemical indicators for sterilization | chemical indicator strips ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K103218 | Class II | Active |
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Manufacturer
- Manufacturer
- Advanced Sterilization Products
Sources (1)
- FDA 510(k) K103218 24 fields · synced Sep 24, 2026