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510(k) K971663

WELLCOLEX E.COLI O157:H7 by Murex Biotech , Ltd. — Product Code GMZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1997
Date Received
May 6, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, All Types, Escherichia Coli
Device Class
Class I
Regulation Number
866.3255
Review Panel
MI
Submission Type

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