Abtox Serilization Process Biological Indicator
FDA 510(k) K923739 · Abtox, Inc.
510(k) numberK923739
Submission
- Device name
- Abtox Serilization Process Biological Indicator
- Applicant
- Abtox, Inc.
Mundelein, IL, US - Received
- July 27, 1992
- Decision date
- December 22, 1994
- 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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Questions and answers
When was Abtox Serilization Process Biological Indicator cleared by the FDA?
Abtox Serilization Process Biological Indicator (K923739) received a 510(k) decision of Substantially Equivalent on December 22, 1994, 878 days after the submission was received.
What is the product code of K923739?
The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.