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510(k) K051484

ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM. by Zeus Scientific, Inc. — Product Code LFY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2005
Date Received
June 6, 2005
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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