510(k) K113249

TRANSPORT CULTURE MEDIUM DEVICE by Puritan Medical Products, LLC — Product Code JSM

K113249 is an FDA 510(k) premarket notification submitted by Puritan Medical Products, LLC for the device "TRANSPORT CULTURE MEDIUM DEVICE". The FDA issued a decision of Substantially Equivalent on March 1, 2012. 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
March 1, 2012
Date Received
November 3, 2011
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