Home / 510(k) Clearances / K946353

510(k) K946353

EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY by Mrl Diagnostics — Product Code LLM

K946353 is an FDA 510(k) premarket notification submitted by Mrl Diagnostics for the device "EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY". The FDA issued a decision of Substantially Equivalent on July 21, 1995. The device falls under product code LLM (Test, Antigen, Nuclear, Epstein-Barr Virus), a Class I device regulated under 21 CFR 866.3235. Mrl Diagnostics has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1995
Date Received
December 30, 1994
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 Mrl Diagnostics

  • K000238 — HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G (April 14, 2000)
  • K993754 — HSV-1 ELISA IGG, MODEL EL0910G (February 9, 2000)
  • K993724 — HSV-2 ELISA IGG, MODEL EL0920G (February 1, 2000)
  • K971006 — LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G) (June 1, 1998)
  • K971007 — LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M) (June 1, 1998)
  • K931520 — EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY (April 26, 1994)

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)
  • K946158 — INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT (June 9, 1995)
  • K932742 — EBNA IGG ELISA TEST SYSTEM (May 5, 1995)

FDA data resources