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510(k) K953839

PREMIER HSV PLUS by Meridian Diagnostics, Inc. — Product Code LGC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1996
Date Received
August 16, 1995
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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Other clearances for product code LGC

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  • K983656 — HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM (March 18, 1999)
  • K983541 — HSV 1+2 IGG ELISA TEST (February 26, 1999)
  • K981306 — DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM (September 29, 1998)