Spor-Test-Strip
FDA 510(k) K801678 · Sterilization Technical Services, Inc.
510(k) numberK801678
Submission
- Device name
- Spor-Test-Strip
- Applicant
- Sterilization Technical Services, Inc.
Walker, MI, US - Received
- July 22, 1980
- Decision date
- August 13, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Spor-Test-Strip cleared by the FDA?
Spor-Test-Strip (K801678) received a 510(k) decision of Substantially Equivalent on August 13, 1980, 22 days after the submission was received.
What is the product code of K801678?
The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.