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510(k) K852494

CMV-IHA by Hillcrest Biologicals — Product Code LJO

K852494 is an FDA 510(k) premarket notification submitted by Hillcrest Biologicals for the device "CMV-IHA". The FDA issued a decision of Substantially Equivalent on September 16, 1985. The device falls under product code LJO (Antigen, Iha, Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. Hillcrest Biologicals has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1985
Date Received
June 12, 1985
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 Hillcrest Biologicals

  • K913618 — ARBOVIRUS IGM IFA TEST (December 3, 1992)
  • K913617 — ARBOVIRUS IGG IFA TEST (December 3, 1992)
  • K922374 — Q FEVER IGM IFA TEST (October 21, 1992)
  • K913906 — Q FEVER IGG IFA TEST (October 21, 1992)
  • K900206 — LYME DISEASE IGM ELISA (June 28, 1991)
  • K896594 — EBV VCA ANTIBODY (IGM) (January 16, 1990)
  • K884829 — EBV EARLY ANTIGEN (R+D) (April 12, 1989)
  • K883767 — LYME DISEASE IFA (IGM) (March 15, 1989)
  • K884591 — EBV-VCA ANTIBODY (IGG) (January 24, 1989)
  • K883487 — LYME DISEASE IFA (IGG) (December 13, 1988)

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)
  • K920222 — HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS (July 27, 1992)
  • K910003 — CYTOMEGALOVIRUS ANTIBODY SCREEN (March 20, 1991)
  • K841520 — CMV LATEX AGGLUTINATION TEST KIT (September 7, 1984)

FDA data resources