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510(k) K021123

BACT/ALERT SN CULTURE BOTTLE by bioMerieux, Inc. — Product Code MDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2002
Date Received
April 8, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Blood Culturing
Device Class
Class I
Regulation Number
866.2560
Review Panel
MI
Submission Type

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