Aerobic Foam Swab Culturette(R)
FDA 510(k) K913789 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK913789
Submission
- Device name
- Aerobic Foam Swab Culturette(R)
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- August 23, 1991
- Decision date
- October 9, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JSM – Culture Media, Non-Propagating Transport
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2390
- Specialty
- Microbiology
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Questions and answers
When was Aerobic Foam Swab Culturette(R) cleared by the FDA?
Aerobic Foam Swab Culturette(R) (K913789) received a 510(k) decision of Substantially Equivalent on October 9, 1991, 47 days after the submission was received.
What is the product code of K913789?
The FDA product code is JSM – Culture Media, Non-Propagating Transport, a Class I (low risk) device regulated under 21 CFR 866.2390.