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510(k) K990263

IMMUNOCARD STAT! E. COLI O157:H7 by Meridian Diagnostics, Inc. — Product Code GMZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1999
Date Received
January 27, 1999
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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