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510(k) K843077

ELISA FOR HERPES SIMPLEX VIRUS by Scientific Research — Product Code LGC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1985
Date Received
August 6, 1984
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

Other clearances by Scientific Research

  • K912420 — ORTHOFIX UNREAMED TIBIAL NAIL SYSTEM (September 23, 1991)
  • K842887 — HERPES VIRUS AGGLUTINATION TEST (February 26, 1985)
  • K843369 — AGGLUTINATION TEST FOR TOTAL IGE (November 14, 1984)
  • K843710 — ELISA FOR TOTAL IGE (October 22, 1984)

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  • K992166 — THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYM (September 3, 1999)
  • K983886 — POCKIT HSV 2 RAPID TEST (August 19, 1999)
  • K984346 — PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST (June 25, 1999)
  • 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)