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510(k) K992587

EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM by Stellar Bio Systems, Inc. — Product Code LSE

K992587 is an FDA 510(k) premarket notification submitted by Stellar Bio Systems, Inc. for the device "EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on December 22, 1999. The device falls under product code LSE (Epstein-Barr Virus, Other), a Class I device regulated under 21 CFR 866.3235. Stellar Bio Systems, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1999
Date Received
August 2, 1999
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 Stellar Bio Systems, Inc.

  • K990915 — INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY (April 21, 1999)
  • K990916 — INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY (April 21, 1999)
  • K914953 — IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY (February 19, 1992)
  • K905608 — INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1 (November 7, 1991)
  • K900974 — INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI. (April 16, 1990)
  • K882835 — INDIRECT FLUORESCENT ASSAY FOR (HCMV) (December 5, 1988)

Other clearances for product code LSE

  • K233606 — ADVIA Centaur EBV-VCA IgM (August 7, 2024)
  • 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)
  • K062213 — BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (December 8, 2006)
  • K062211 — BIOPLEX 2200 EBV IGG PANEL FOR 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)

FDA data resources