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510(k) K874849

PROSPECT/GIARDIA by Alexon Biomedical, Inc. — Product Code KHW

K874849 is an FDA 510(k) premarket notification submitted by Alexon Biomedical, Inc. for the device "PROSPECT/GIARDIA". The FDA issued a decision of Substantially Equivalent on January 5, 1988. 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. Alexon Biomedical, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1988
Date Received
November 25, 1987
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 Alexon Biomedical, Inc.

  • K964864 — PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY (February 4, 1997)
  • K955157 — PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY (February 9, 1996)
  • K936191 — PROSPECT CRYPTOSPORIDIUM RAPID ASSAY (November 17, 1994)
  • K933997 — PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY (November 22, 1993)

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)
  • K870318 — AMEBIASIS ELISA TEST KIT (August 11, 1987)
  • K863811 — AMEBIASIS MICROASSAY (October 9, 1986)

FDA data resources