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510(k) K903070

SEROCARD HSV IGG ANTIBODY TEST KIT by Disease Detection International, Inc. — Product Code LGC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1990
Date Received
July 12, 1990
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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  • K983541 — HSV 1+2 IGG ELISA TEST (February 26, 1999)
  • K981306 — DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM (September 29, 1998)