510(k) K131630
K131630 is an FDA 510(k) premarket notification submitted by Puritan Medical Products, LLC for the device "PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM". The FDA issued a decision of Substantially Equivalent on October 21, 2013. The device falls under product code LIO (Device, Specimen Collection), a Class I device regulated under 21 CFR 866.2900. Puritan Medical Products, LLC has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 2013
- Date Received
- June 4, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Specimen Collection
- Device Class
- Class I
- Regulation Number
- 866.2900
- Review Panel
- MI
- Submission Type