Sterraad 100NX Express Cycle Test Pack
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K092755 FDA 510(k)
- FDA Product Code
- FRC 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 Sterraad 100NX Express Cycle Test Pack is a biological sterilization process indicator designed for monitoring sterilization cycles. It is used to verify that sterilization parameters have been met during the sterilization process.
This test pack is supplied as a single-use device and is not for MRI use. It is regulated under FDA 510K clearance with product code FRC and device class 2. The device is intended for use in general hospital settings.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K092755 | Class II | Active |
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Manufacturer
- Manufacturer
- Advanced Sterilization Products
Sources (1)
- FDA 510(k) K092755 24 fields · synced Sep 21, 2026