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510(k) K213987

ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls by Biokit, S.A. — Product Code MXJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2023
Date Received
December 20, 2021
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

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  • K181334 — ADVIA Centaur Herpes-2 IgG (August 23, 2018)
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  • K152185 — ARCHITECT SHBG (February 11, 2016)
  • K132400 — LP(A) CALIBRATORS, AND LP(A) CONTROLS (December 19, 2013)
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Other clearances for product code MXJ

  • 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)
  • K081685 — LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG (November 18, 2008)