Enterix Insurefit Fob Controls, Model 16800
FDA 510(k) K101831 · Bionostics, Inc.
510(k) numberK101831
Submission
- Device name
- Enterix Insurefit Fob Controls, Model 16800
- Applicant
- Bionostics, Inc.
Devens, MA, US - Received
- July 1, 2010
- Decision date
- October 1, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OSL – Control, Fecal Occult Blood
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.6550
- Specialty
- Hematology
Fecal occult blood controls (Negative and positive) are used to verify the performance of the fecal occult blood test devices.
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Questions and answers
When was Enterix Insurefit Fob Controls, Model 16800 cleared by the FDA?
Enterix Insurefit Fob Controls, Model 16800 (K101831) received a 510(k) decision of Substantially Equivalent on October 1, 2010, 92 days after the submission was received.
What is the product code of K101831?
The FDA product code is OSL – Control, Fecal Occult Blood, a Class II (moderate risk) device regulated under 21 CFR 864.6550.