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510(k) K851949

STAPHAUREX ZL30 by Wellcome Diagnostics — Product Code GTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1985
Date Received
May 3, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Fluorescent, All Types, Staphylococcus Spp.
Device Class
Class I
Regulation Number
866.3700
Review Panel
MI
Submission Type

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