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510(k) K983541

HSV 1+2 IGG ELISA TEST by Gull Laboratories, Inc. — Product Code LGC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1999
Date Received
October 9, 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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  • K932333 — PROTECTORAL ULTRASONIC HANDPIECE PROCESSOR (August 15, 1995)
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  • K922758 — HSV-1 IGM ELISA TEST -- MODIFICATION (October 5, 1992)
  • K922759 — HSV-2 IGM ELISA TEST--MODIFICATION (October 5, 1992)

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  • K983656 — HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM (March 18, 1999)
  • K981306 — DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM (September 29, 1998)
  • K963645 — HERPES GROUP IGG ELISA TEST SYSTEM (February 4, 1997)