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510(k) K070317

ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM by Zeus Scientific, Inc. — Product Code LFY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 2007
Date Received
February 2, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
Device Class
Class II
Regulation Number
866.3900
Review Panel
MI
Submission Type

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