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510(k) K203612

Capture-CMV by Immucor, Inc. — Product Code LJO

K203612 is an FDA 510(k) premarket notification submitted by Immucor, Inc. for the device "Capture-CMV". The FDA issued a decision of Substantially Equivalent on March 22, 2021. The device falls under product code LJO (Antigen, Iha, Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. Immucor, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2021
Date Received
December 10, 2020
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 Immucor, Inc.

  • K183571 — Capture-CMV (February 4, 2019)
  • K910003 — CYTOMEGALOVIRUS ANTIBODY SCREEN (March 20, 1991)

Other clearances for product code LJO

  • 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)
  • K955799 — COPALIS CMV TOTAL ANTIBODY ASSAY (July 10, 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)

FDA data resources