Bacillum Pumilus Spore Strips
FDA 510(k) K810930 · Oxoid U.S.A., Inc.
510(k) numberK810930
Submission
- Device name
- Bacillum Pumilus Spore Strips
- Applicant
- Oxoid U.S.A., Inc.
Walker, MI, US - Received
- April 6, 1981
- Decision date
- June 16, 1981
- 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 Bacillum Pumilus Spore Strips cleared by the FDA?
Bacillum Pumilus Spore Strips (K810930) received a 510(k) decision of Substantially Equivalent on June 16, 1981, 71 days after the submission was received.
What is the product code of K810930?
The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.