K242820
- 510(k) number
- K242820
- Device name
- Puritan PurSafe Plus Collection and Transport System
- Applicant
- Puritan Medical Products, LLC ME · US
- Product code
- QBD — Microbial Nucleic Acid Storage And Stabilization Dev
- Decision date
- 2025-05-27
- Date received
- 2024-09-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K242820.pdf
Official FDA record: K242820
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.