Home / 510(k) Clearances / K993724

510(k) K993724

HSV-2 ELISA IGG, MODEL EL0920G by Mrl Diagnostics — Product Code MYF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2000
Date Received
November 3, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Device Class
Class II
Regulation Number
866.3305
Review Panel
MI
Submission Type

Other clearances by Mrl Diagnostics

  • K000238 — HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G (April 14, 2000)
  • K993754 — HSV-1 ELISA IGG, MODEL EL0910G (February 9, 2000)
  • K971006 — LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G) (June 1, 1998)
  • K971007 — LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M) (June 1, 1998)
  • K946353 — EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY (July 21, 1995)
  • K931520 — EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY (April 26, 1994)

Other clearances for product code MYF

  • K243575 — ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Control (February 12, 2025)
  • K220924 — Elecsys HSV-2 IgG (08948887160) (October 12, 2022)
  • K181514 — SeraQuest HSV Type 2 Specific IgG (June 13, 2019)
  • K181334 — ADVIA Centaur Herpes-2 IgG (August 23, 2018)
  • K152353 — SeraQuest HSV Type 2 Specific IgG (May 13, 2016)
  • K103603 — ZEUS ELISA HSV GG-2 IGG TEST SYSTEM (May 20, 2011)
  • K081687 — LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG (November 10, 2008)
  • K061239 — EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT (June 28, 2007)
  • K033106 — CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT (July 13, 2004)