Dermatophyte Test Medium, Slants and Mycoflasks
FDA 510(k) K863525 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK863525
Submission
- Device name
- Dermatophyte Test Medium, Slants and Mycoflasks
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- September 10, 1986
- Decision date
- September 19, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSI – Culture Media, Selective And Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2360
- Specialty
- Microbiology
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Questions and answers
When was Dermatophyte Test Medium, Slants and Mycoflasks cleared by the FDA?
Dermatophyte Test Medium, Slants and Mycoflasks (K863525) received a 510(k) decision of Substantially Equivalent on September 19, 1986, 9 days after the submission was received.
What is the product code of K863525?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.