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510(k) K831133

AMEBIASIS BIO-ENZABEAD SCREEN KIT by Bionetic Laboratory Products — Product Code KHW

K831133 is an FDA 510(k) premarket notification submitted by Bionetic Laboratory Products for the device "AMEBIASIS BIO-ENZABEAD SCREEN KIT". The FDA issued a decision of Substantially Equivalent on June 8, 1983. 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. Bionetic Laboratory Products has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1983
Date Received
April 7, 1983
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 Bionetic Laboratory Products

  • K833637 — VZV BIO-ENZABEAD SCREEN KIT (February 10, 1984)
  • K832900 — IMMUNOENZYME TEST SYS-DETECT-IGM ANTI (November 14, 1983)
  • K832069 — TOXO IPA KIT IAN INDIRECT FLUORESCENT (September 26, 1983)
  • K831760 — LEGIONELLA IFA KIT I (August 8, 1983)
  • K830820 — LEGIONELLA DFA KIT I (June 8, 1983)
  • K830405 — LBI-100 37DEGREES INCUBATOR (March 10, 1983)
  • K830227 — AUTOMATED ELISA READER LBI 300 (March 10, 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)
  • 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