510(k) K160082

Puritan Opti-Tranz Cary-Blair Collection and Transport System by Puritan Medical Products, LLC — Product Code JSM

K160082 is an FDA 510(k) premarket notification submitted by Puritan Medical Products, LLC for the device "Puritan Opti-Tranz Cary-Blair Collection and Transport System". The FDA issued a decision of Substantially Equivalent on July 29, 2016. 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
July 29, 2016
Date Received
January 15, 2016
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