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510(k) K843077

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

K843077 is an FDA 510(k) premarket notification submitted by Scientific Research for the device "ELISA FOR HERPES SIMPLEX VIRUS". The FDA issued a decision of Substantially Equivalent on June 21, 1985. The device falls under product code LGC (Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific), a Class II device regulated under 21 CFR 866.3305. Scientific Research has at least 4 other 510(k) clearances on record.

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)

Other clearances for product code LGC

  • K033059 — HERPES GROUP IGG (November 26, 2003)
  • K010878 — MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6 (April 18, 2001)
  • K002262 — DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM (November 28, 2000)
  • K000238 — HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G (April 14, 2000)
  • 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)

FDA data resources