Home / 510(k) Clearances / K980912

510(k) K980912

VCA IGG ELISA TEST SYSTEM by Clark Laboratories, Inc. — Product Code LSE

K980912 is an FDA 510(k) premarket notification submitted by Clark Laboratories, Inc. for the device "VCA IGG ELISA TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on July 22, 1998. The device falls under product code LSE (Epstein-Barr Virus, Other), a Class I device regulated under 21 CFR 866.3235. Clark Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1998
Date Received
March 10, 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 Clark Laboratories, Inc.

  • K980596 — VCA IGM ELISA TEST SYSTEM (July 22, 1998)
  • K980598 — EBNA-1 IGM ELISA TEST SYSTEM (May 1, 1998)
  • K973123 — EA-D IGG ELISA TEST SYSTEM (March 26, 1998)
  • K931543 — ENCORE ENA COMBINED EIA (September 8, 1993)
  • K925826 — ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA (January 26, 1993)
  • K923537 — ENCORE DS-DNA (December 23, 1992)
  • K921572 — ENCORE SM (December 1, 1992)
  • K921870 — ENCORE SM/RNP (December 1, 1992)
  • K922340 — ENCORE SS-B (October 16, 1992)
  • K922157 — ENCORE SS-A (October 13, 1992)

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)
  • 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)

FDA data resources