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510(k) K983839

BIOTEST ANTI-EBV RECOMBINANT by Biotest Diagnostics Corp. — Product Code LSE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1999
Date Received
October 30, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Epstein-Barr Virus, Other
Device Class
Class I
Regulation Number
866.3235
Review Panel
MI
Submission Type

Other clearances by Biotest Diagnostics Corp.

  • K991650 — CMV BRITE TURBO KIT (July 12, 1999)
  • K983842 — BIOTEST ANTI-EBV RECOMBINANT, EA IGM (June 9, 1999)
  • K983841 — BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG (June 9, 1999)
  • K951550 — CMV BRITE ANTIGENEMIA TEST KIT (January 30, 1996)

Other clearances for product code LSE

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  • K162961 — LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and L (January 5, 2017)
  • K162959 — LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set (January 4, 2017)
  • K091260 — SERAQUEST EBV EA-D IGG TEST (June 8, 2009)
  • K073382 — PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G (July 28, 2008)
  • K062211 — BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (December 8, 2006)
  • K062213 — BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (December 8, 2006)
  • K060204 — LIAISON EA IGG (October 18, 2006)
  • K033915 — MODIFICATION TO SERAQUEST EB VCA IGG (January 16, 2004)
  • K030863 — EBV VCA-P18 IGG ELISA (June 27, 2003)