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510(k) K920222

HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS by Akers Research Corp. — Product Code LJO

K920222 is an FDA 510(k) premarket notification submitted by Akers Research Corp. for the device "HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS". The FDA issued a decision of Substantially Equivalent on July 27, 1992. The device falls under product code LJO (Antigen, Iha, Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. Akers Research Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1992
Date Received
January 16, 1992
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 Akers Research Corp.

  • K920221 — HEALTHTEST INFECTIOUS MONONUCLEOSIS ASSAY (March 13, 1992)
  • K920220 — HEALTHTEST RHEUMATOID FACTOR ASSAY (March 13, 1992)

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)
  • K955799 — COPALIS CMV TOTAL ANTIBODY ASSAY (July 10, 1996)
  • 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