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510(k) K844967

ECHO TYPE 9 CF ANTIGEN by Hillcrest Biologicals — Product Code GNL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1985
Date Received
December 24, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Cf (Including Cf Control), Echovirus 1-34
Device Class
Class I
Regulation Number
866.3205
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)
  • K913906 — Q FEVER IGG IFA TEST (October 21, 1992)
  • K922374 — Q FEVER IGM 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 GNL

  • K844695 — ECHO TYPE 4 CF ANTIGEN (March 5, 1985)