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510(k) K853448

HILLCREST AMEBIASIS IHA TEST by Hillcrest Biologicals — Product Code KHW

K853448 is an FDA 510(k) premarket notification submitted by Hillcrest Biologicals for the device "HILLCREST AMEBIASIS IHA TEST". The FDA issued a decision of Substantially Equivalent on August 28, 1985. The device falls under product code KHW (Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.), a Class II device regulated under 21 CFR 866.3220. Hillcrest Biologicals has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1985
Date Received
August 16, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
Device Class
Class II
Regulation Number
866.3220
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)

Other clearances for product code KHW

  • K170728 — E. HISTOLYTICA QUIK CHEK (June 7, 2017)
  • K994101 — E. HISTOLYTICA II (December 21, 1999)
  • K955895 — E. HISTOLYTICA TEST (August 30, 1996)
  • K954996 — TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM (August 8, 1996)
  • K944791 — ENTAMOEBA TEST (March 9, 1995)
  • K900604 — DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA (July 26, 1990)
  • K890774 — GIARDEIA(TM) (April 4, 1989)
  • K890003 — GIARDIA STOOL ANTIGEN TEST KIT (March 14, 1989)
  • K874849 — PROSPECT/GIARDIA (January 5, 1988)
  • K870318 — AMEBIASIS ELISA TEST KIT (August 11, 1987)

FDA data resources