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510(k) K895708

EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI) by Immuno Concepts, Inc. — Product Code LLM

K895708 is an FDA 510(k) premarket notification submitted by Immuno Concepts, Inc. for the device "EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI)". The FDA issued a decision of Substantially Equivalent on December 11, 1989. The device falls under product code LLM (Test, Antigen, Nuclear, Epstein-Barr Virus), a Class I device regulated under 21 CFR 866.3235. Immuno Concepts, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1989
Date Received
September 25, 1989
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 Immuno Concepts, Inc.

  • K013432 — IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G (November 29, 2001)
  • K013285 — RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15 (November 14, 2001)
  • K013283 — RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16 (November 14, 2001)
  • K992041 — RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11 (July 23, 1999)
  • K983924 — HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO (December 18, 1998)
  • K972145 — HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM (February 24, 1998)
  • K974478 — IMMUNO CONCEPTS ANCA TEST SYSTEMS (February 9, 1998)
  • K974463 — IMMUNO CONCEPTS ANCA TEST SYSTEM (February 9, 1998)
  • K963275 — RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM (September 13, 1996)
  • K955603 — RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM (April 19, 1996)

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)
  • K980598 — EBNA-1 IGM ELISA TEST SYSTEM (May 1, 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)

FDA data resources