Attest Rapid Readout Biological Indicator, Mode 1292
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- K090569 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 Attest Rapid Readout Biological Indicator, Mode 1292, is a biological sterilization process indicator. It is used to verify the effectiveness of sterilization processes.
The device is supplied as a single-use indicator and is intended for use in a general hospital setting. It is available in various sizes and is stored at room temperature. The device has been authorized with an FDA 510K clearance, with a regulation number of 880.2800 and a product code of FRC.
Frequently asked questions
What is the Attest 1292 Biological Indicator used for?
The Attest 1292 Biological Indicator is used to verify the effectiveness of sterilization processes in a general hospital setting.
Is the Attest 1292 Biological Indicator reusable?
No, the Attest 1292 Biological Indicator is supplied as a single-use indicator.
How is the Attest 1292 Biological Indicator stored?
The Attest 1292 Biological Indicator is stored at room temperature.
What sizes is the Attest 1292 Biological Indicator available in?
The Attest 1292 Biological Indicator is available in various sizes.
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 | K090569 | Class II | Active |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) K090569 24 fields · synced Sep 25, 2026