UriSponge— 510(k) K232565
Substantially EquivalentCopan Italia Spa
FDA 510(k) clearance K232565 for UriSponge, Substantially Equivalent on 2024-10-11. Applicant: Copan Italia Spa. Device class: 1.
Clearance details
- Applicant
- Copan Italia Spa
- Product code
- Code JSM
- Device class
- Class 1
- Regulation
- 21 CFR 866.2390
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brescia, IT
Recent devices under product code JSM
view allMore clearances from Copan Italia Spa
view all- K232357 — Copan Universal Transport Medium (UTM-RT) System
- K220052 — Copan FecalSwab Collection, Transport and Preservation System
- K201849 — eNAT molecular collection and preservation medium
- K180052 — UriSwab-Urine Collection, Transport and Preservation System
- K142094 — COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.