Andersen EOGas 4 SteriTest
FDA 510(k) K151585 · Andersen Sterilizers, Inc.
510(k) numberK151585
Submission
- Device name
- Andersen EOGas 4 SteriTest
- Applicant
- Andersen Sterilizers, Inc.
Haw River, NC, US - Received
- June 11, 2015
- Decision date
- November 18, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRC – Indicator, Biological Sterilization Process
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2800
- Specialty
- General Hospital
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| K170439 | AN87 DosimeterJOJ · Traditional | 11/01/2017SE |
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| K170432 | Anprolene AN75 Ethylene Oxide Gas SterilizerFLF · Traditional | 10/31/2017SE |
Questions and answers
When was Andersen EOGas 4 SteriTest cleared by the FDA?
Andersen EOGas 4 SteriTest (K151585) received a 510(k) decision of Substantially Equivalent on November 18, 2015, 160 days after the submission was received.
What is the product code of K151585?
The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.