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510(k) K031737

BACT/ALERT MP CULTURE BOTTLES (PLASTIC) by bioMerieux, Inc. — Product Code MDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2003
Date Received
June 4, 2003
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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