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510(k) K984346

PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST by Meridian Diagnostics, Inc. — Product Code LGC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1999
Date Received
December 4, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
Device Class
Class II
Regulation Number
866.3305
Review Panel
MI
Submission Type

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