510(k) K013819

URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM by Sierra Diagnostic, LLC — Product Code JTW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2002
Date Received
November 16, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Transport, Aerobic
Device Class
Class I
Regulation Number
866.2900
Review Panel
MI
Submission Type