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510(k) K021486

HERPESELECT 2 ELISA IGG, MODEL ELO920G by Focus Technologies, Inc. — Product Code MXJ

K021486 is an FDA 510(k) premarket notification submitted by Focus Technologies, Inc. for the device "HERPESELECT 2 ELISA IGG, MODEL ELO920G". The FDA issued a decision of Substantially Equivalent on August 1, 2002. 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. Focus Technologies, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2002
Date Received
May 3, 2002
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 Focus Technologies, Inc.

  • K040854 — WEST NILE VIRUS IGM CAPTURE ELISA (June 30, 2004)
  • K031953 — WEST NILE VIRUS ELISA IGG, MODEL EL0300G (October 22, 2003)
  • K031952 — WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M (October 22, 2003)
  • K021429 — HERPESELECT 1 ELISA IGG, MODEL EL0910G (July 29, 2002)

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