Bacti-Swab Dry
FDA 510(k) K013711 · Remel Co.
510(k) numberK013711
Submission
- Device name
- Bacti-Swab Dry
- Applicant
- Remel Co.
Lenexa, KS, US - Received
- November 7, 2001
- Decision date
- November 26, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LIO – Device, Specimen Collection
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2900
- Specialty
- Microbiology
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Questions and answers
When was Bacti-Swab Dry cleared by the FDA?
Bacti-Swab Dry (K013711) received a 510(k) decision of Substantially Equivalent on November 26, 2001, 19 days after the submission was received.
What is the product code of K013711?
The FDA product code is LIO – Device, Specimen Collection, a Class I (low risk) device regulated under 21 CFR 866.2900.