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510(k) K864110

RICKETTSIAL IGG AND IGM IFA KIT by Hillcrest Biologicals — Product Code GPN

K864110 is an FDA 510(k) premarket notification submitted by Hillcrest Biologicals for the device "RICKETTSIAL IGG AND IGM IFA KIT". The FDA issued a decision of Substantially Equivalent on March 12, 1987. The device falls under product code GPN (Antiserum, Typhus Fever), a Class I device regulated under 21 CFR 866.3500. Hillcrest Biologicals has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1987
Date Received
October 21, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Typhus Fever
Device Class
Class I
Regulation Number
866.3500
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)

FDA data resources