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510(k) K121039

COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM by Copan Flock Technologies — Product Code JTW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2012
Date Received
April 5, 2012
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

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  • K983244 — SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM) (November 30, 1998)
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  • K934894 — CULTURESWAB TRANSPORT SYSTEM (February 22, 1994)
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  • K895187 — FDL, INC.'S TRANSPORT SYSTEM (October 24, 1989)
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