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510(k) K993554

YEASTEST by Diagnostic Markers, Inc. — Product Code JXB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2000
Date Received
October 20, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Identification, Yeast
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

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