Home / 510(k) Clearances / K884829

510(k) K884829

EBV EARLY ANTIGEN (R+D) by Hillcrest Biologicals — Product Code JRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1989
Date Received
November 18, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Fluorescent, Epstein-Barr Virus
Device Class
Class I
Regulation Number
866.3235
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)
  • K883767 — LYME DISEASE IFA (IGM) (March 15, 1989)
  • K884591 — EBV-VCA ANTIBODY (IGG) (January 24, 1989)
  • K883487 — LYME DISEASE IFA (IGG) (December 13, 1988)
  • K875170 — EBNA ANTIBODY (May 23, 1988)

Other clearances for product code JRY

  • K042118 — ATHENA MULTI-LYTE EBV IGG TEST SYSTEM (April 29, 2005)
  • K900974 — INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI. (April 16, 1990)
  • K891785 — BION EBV-G (VCA) TEST SYSTEM (August 31, 1989)
  • K822734 — EBV IGM TEST (December 9, 1982)
  • K822985 — EBV-M KIT (December 3, 1982)
  • K821849 — EBV-VCA ANTIBODY ASSAY KIT (August 12, 1982)
  • K811262 — EPSTEIN-BARR VIRUS CAPSID ANTIGEN ANTI (May 27, 1981)
  • K780925 — EB-VCA, TEST, ANTIBODY, FLUORESCENT (June 22, 1978)