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510(k) K910499

IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS by Vitek Systems, Inc. — Product Code LGC

K910499 is an FDA 510(k) premarket notification submitted by Vitek Systems, Inc. for the device "IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS". The FDA issued a decision of Substantially Equivalent on May 1, 1991. 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. Vitek Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1991
Date Received
February 5, 1991
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 Vitek Systems, Inc.

  • K920661 — VIDAS CMV IGG ASSAY (February 12, 1993)
  • K921302 — VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (July 28, 1992)
  • K921176 — VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (April 8, 1992)
  • K920952 — VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY (April 7, 1992)
  • K915884 — VIDAS CHLAMYDIA ASSAY, MODIFICATION (March 4, 1992)
  • K905211 — VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY (October 11, 1991)
  • K912371 — BIOMERIEUX RSV DIRECT IF KIT (September 23, 1991)
  • K910230 — LYME-SPOT IF KIT (August 30, 1991)
  • K910210 — SLIDEX MENINGITE-KIT 5 (August 12, 1991)
  • K910304 — RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA (July 26, 1991)

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