K220908
- 510(k) number
- K220908
- Device name
- Ensol EnTM Specimen Collection and Transport System
- Applicant
- Ensol Biosciences, Inc. KR
- Product code
- JSM — Culture Media, Non-Propagating Transport
- Decision date
- 2024-08-29
- Date received
- 2022-03-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K220908.pdf
Official FDA record: K220908
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.