510(k) K001780

COPAN VIRAL TRANSYSTEM by Copan Diagnostics, Inc. — Product Code JSM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2001
Date Received
June 13, 2000
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