Sportrol Rapid Sterility Indicator
FDA 510(k) K962649 · North American Science Assoc., Inc.
510(k) numberK962649
Submission
- Device name
- Sportrol Rapid Sterility Indicator
- Applicant
- North American Science Assoc., Inc.
Northwood, OH, US - Received
- July 8, 1996
- Decision date
- September 26, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MTC – Indicator, Chemical, Enzymatic, 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 Sportrol Rapid Sterility Indicator cleared by the FDA?
Sportrol Rapid Sterility Indicator (K962649) received a 510(k) decision of Substantially Equivalent on September 26, 1997, 445 days after the submission was received.
What is the product code of K962649?
The FDA product code is MTC – Indicator, Chemical, Enzymatic, Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.