Eztest-Steam
FDA 510(k) K930682 · Sgm Biotech, Inc.
510(k) numberK930682
Submission
- Device name
- Eztest-Steam
- Applicant
- Sgm Biotech, Inc.
Bozeman, MT, US - Received
- February 10, 1993
- Decision date
- April 4, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K242538 | 3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam…FRC · Traditional | 3M Company | 11/25/2024SE |
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Questions and answers
When was Eztest-Steam cleared by the FDA?
Eztest-Steam (K930682) received a 510(k) decision of Substantially Equivalent on April 4, 1994, 418 days after the submission was received.
What is the product code of K930682?
The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.