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510(k) K983541

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

K983541 is an FDA 510(k) premarket notification submitted by Gull Laboratories, Inc. for the device "HSV 1+2 IGG ELISA TEST". The FDA issued a decision of Substantially Equivalent on February 26, 1999. 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. Gull Laboratories, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Gull Laboratories, Inc.

  • K971857 — MUMPS IGG ELISA TESTY (November 4, 1997)
  • K962343 — TOXO IGG ELISA TEST (March 24, 1997)
  • K935730 — EBNA IGG ELISA TEST (September 19, 1995)
  • K940093 — EBV-EA(D) IGG ELISA TEST (September 15, 1995)
  • K941046 — VZV IGG ELISA TEST (August 24, 1995)
  • K941198 — EBV LGG ELISA TEST (August 23, 1995)
  • K932333 — PROTECTORAL ULTRASONIC HANDPIECE PROCESSOR (August 15, 1995)
  • K941624 — RUBELLA IGG ELISA TEST (August 4, 1995)
  • K922758 — HSV-1 IGM ELISA TEST -- MODIFICATION (October 5, 1992)
  • K922759 — HSV-2 IGM ELISA TEST--MODIFICATION (October 5, 1992)

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)
  • K981306 — DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM (September 29, 1998)
  • K963645 — HERPES GROUP IGG ELISA TEST SYSTEM (February 4, 1997)

FDA data resources