510(k) K946287

COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL by Copan Diagnostics, Inc. — Product Code JSM

K946287 is an FDA 510(k) premarket notification submitted by Copan Diagnostics, Inc. for the device "COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL". The FDA issued a decision of Substantially Equivalent on March 10, 1995. The device falls under product code JSM (Culture Media, Non-Propagating Transport), a Class I device regulated under 21 CFR 866.2390. Copan Diagnostics, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1995
Date Received
December 27, 1994
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