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510(k) K954996

TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM by Trend Scientific, Inc. — Product Code KHW

K954996 is an FDA 510(k) premarket notification submitted by Trend Scientific, Inc. for the device "TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on August 8, 1996. 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. Trend Scientific, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1996
Date Received
November 1, 1995
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 Trend Scientific, Inc.

  • K955755 — TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMS (July 11, 1996)
  • K952467 — TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT) (November 20, 1995)
  • K953284 — TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM (October 6, 1995)
  • K862914 — FEKAL CHECK PARASITOLOGY CONTROL SLIDE (September 16, 1986)
  • K830769 — FEKAL CON-TRATE SYSTEM (April 5, 1983)

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)
  • 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)
  • K863811 — AMEBIASIS MICROASSAY (October 9, 1986)

FDA data resources