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510(k) K955799

COPALIS CMV TOTAL ANTIBODY ASSAY by Sienna Biotech, Inc. — Product Code LJO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1996
Date Received
December 22, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Iha, Cytomegalovirus
Device Class
Class II
Regulation Number
866.3175
Review Panel
MI
Submission Type

Other clearances by Sienna Biotech, Inc.

  • K970931 — COPALIS TORC TOTAL ANTIBODY ASSAY (April 24, 1997)
  • K961784 — COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSA (October 31, 1996)

Other clearances for product code LJO

  • K203612 — Capture-CMV (March 22, 2021)
  • K183571 — Capture-CMV (February 4, 2019)
  • K001767 — DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM (August 7, 2000)
  • K974901 — HYBRID CAPTURE SYSTEM CMV DNA ASSAY (September 29, 1998)
  • K974456 — CMVGEN (May 1, 1998)
  • K951851 — ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY (July 24, 1996)
  • K920222 — HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS (July 27, 1992)
  • K910003 — CYTOMEGALOVIRUS ANTIBODY SCREEN (March 20, 1991)
  • K852494 — CMV-IHA (September 16, 1985)
  • K841520 — CMV LATEX AGGLUTINATION TEST KIT (September 7, 1984)