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510(k) K913906

Q FEVER IGG IFA TEST by Hillcrest Biologicals — Product Code GPJ

K913906 is an FDA 510(k) premarket notification submitted by Hillcrest Biologicals for the device "Q FEVER IGG IFA TEST". The FDA issued a decision of Substantially Equivalent on October 21, 1992. The device falls under product code GPJ (Antiserum, Fluorescent, Q 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
October 21, 1992
Date Received
August 30, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Fluorescent, Q Fever
Device Class
Class I
Regulation Number
866.3500
Review Panel
MI
Submission Type

Other clearances by Hillcrest Biologicals

  • K913617 — ARBOVIRUS IGG IFA TEST (December 3, 1992)
  • K913618 — ARBOVIRUS IGM IFA TEST (December 3, 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)
  • K875170 — EBNA ANTIBODY (May 23, 1988)

Other clearances for product code GPJ

  • K922374 — Q FEVER IGM IFA TEST (October 21, 1992)

FDA data resources