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510(k) K943843

VARICELISA, MODIFICATION by Biowhittaker Molecular Applications, Inc. — Product Code LFY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1996
Date Received
July 28, 1994
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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