Home / 510(k) Clearances / K980598

510(k) K980598

EBNA-1 IGM ELISA TEST SYSTEM by Clark Laboratories, Inc. — Product Code LLM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1998
Date Received
February 17, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Antigen, Nuclear, Epstein-Barr Virus
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)
  • K980912 — VCA IGG ELISA TEST SYSTEM (July 22, 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)
  • K921870 — ENCORE SM/RNP (December 1, 1992)
  • K921572 — ENCORE SM (December 1, 1992)
  • K922340 — ENCORE SS-B (October 16, 1992)
  • K922157 — ENCORE SS-A (October 13, 1992)

Other clearances for product code LLM

  • K233605 — ADVIA Centaur EBV-EBNA IgG (August 7, 2024)
  • K040120 — DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS (April 29, 2005)
  • K984133 — THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME L (January 11, 1999)
  • K973941 — IMMUNOWELL EBNA IGG TEST (August 10, 1998)
  • K951549 — EBNA IGG EIA TEST SYSTEM (April 29, 1996)
  • K951822 — EBNA ENZYME IMMUNOASSAY KIT (February 15, 1996)
  • K935730 — EBNA IGG ELISA TEST (September 19, 1995)
  • K946353 — EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY (July 21, 1995)
  • K946158 — INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT (June 9, 1995)
  • K932742 — EBNA IGG ELISA TEST SYSTEM (May 5, 1995)