Attest Brand Rapid Readout Biological Ind. #129X
FDA 510(k) K926364 · 3M Health Care, Ltd.
510(k) numberK926364
Submission
- Device name
- Attest Brand Rapid Readout Biological Ind. #129X
- Applicant
- 3M Health Care, Ltd.
St. Paul, MN, US - Received
- December 22, 1992
- Decision date
- March 31, 1995
- 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 Attest Brand Rapid Readout Biological Ind. #129X cleared by the FDA?
Attest Brand Rapid Readout Biological Ind. #129X (K926364) received a 510(k) decision of Substantially Equivalent on March 31, 1995, 829 days after the submission was received.
What is the product code of K926364?
The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.