510(k) K142094
K142094 is an FDA 510(k) premarket notification submitted by Copan Italia Spa for the device "COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM". The FDA issued a decision of Substantially Equivalent on April 10, 2015. The device falls under product code JSM (Culture Media, Non-Propagating Transport), a Class I device regulated under 21 CFR 866.2390. Copan Italia Spa has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 2015
- Date Received
- August 1, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Culture Media, Non-Propagating Transport
- Device Class
- Class I
- Regulation Number
- 866.2390
- Review Panel
- MI
- Submission Type