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510(k) K993754

HSV-1 ELISA IGG, MODEL EL0910G by Mrl Diagnostics — Product Code MXJ

K993754 is an FDA 510(k) premarket notification submitted by Mrl Diagnostics for the device "HSV-1 ELISA IGG, MODEL EL0910G". The FDA issued a decision of Substantially Equivalent on February 9, 2000. The device falls under product code MXJ (Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1), a Class II device regulated under 21 CFR 866.3305. Mrl Diagnostics has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2000
Date Received
November 5, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
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)
  • K993724 — HSV-2 ELISA IGG, MODEL EL0920G (February 1, 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 MXJ

  • K213987 — ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Control (September 20, 2023)
  • K220923 — Elecsys HSV-1 IgG (08948844160) (October 12, 2022)
  • K181333 — ADVIA Centaur Herpes-1 IgG (August 23, 2018)
  • K162276 — SeraQuest Herpes Type 1 Specific IgG (October 1, 2016)
  • K143236 — Theranos Herpes Simplex Virus-1 IgG Assay (July 2, 2015)
  • K131334 — HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST (February 28, 2014)
  • K120625 — ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV (July 25, 2012)
  • K120959 — BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT (June 22, 2012)
  • K103363 — ZEUS ELISA HSV GC-I IGG TEST SYSTEM (April 26, 2011)
  • K090409 — BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYS (May 8, 2009)

FDA data resources