510(k) K142366
K142366 is an FDA 510(k) premarket notification submitted by Puritan Medical Products, LLC for the device "Puritan OptiTranz Liquid Stuart Collection and Transport System". The FDA issued a decision of Substantially Equivalent on January 9, 2015. The device falls under product code JSM (Culture Media, Non-Propagating Transport), a Class I device regulated under 21 CFR 866.2390. Puritan Medical Products, LLC has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 2015
- Date Received
- August 25, 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