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510(k) K913617

ARBOVIRUS IGG IFA TEST by Hillcrest Biologicals — Product Code GQC

K913617 is an FDA 510(k) premarket notification submitted by Hillcrest Biologicals for the device "ARBOVIRUS IGG IFA TEST". The FDA issued a decision of Substantially Equivalent on December 3, 1992. The device falls under product code GQC (Antisera, Cf, Equine Encephalitis Virus, Eee, Wee), a Class I device regulated under 21 CFR 866.3240. Hillcrest Biologicals has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1992
Date Received
August 13, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Cf, Equine Encephalitis Virus, Eee, Wee
Device Class
Class I
Regulation Number
866.3240
Review Panel
MI
Submission Type

Other clearances by Hillcrest Biologicals

  • K913618 — ARBOVIRUS IGM 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)
  • K875170 — EBNA ANTIBODY (May 23, 1988)

Other clearances for product code GQC

  • K913618 — ARBOVIRUS IGM IFA TEST (December 3, 1992)

FDA data resources