Home / 510(k) Clearances / K870318

510(k) K870318

AMEBIASIS ELISA TEST KIT by Lmd Laboratories — Product Code KHW

K870318 is an FDA 510(k) premarket notification submitted by Lmd Laboratories for the device "AMEBIASIS ELISA TEST KIT". The FDA issued a decision of Substantially Equivalent on August 11, 1987. 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. Lmd Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1987
Date Received
January 28, 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 Lmd Laboratories

  • K955345 — LMD CRYPTOSPORIDIUM ANTIGEN DETECTION (June 7, 1996)
  • K942705 — E. COLI 0157 ELISA STOOL ASSAY (September 27, 1995)
  • K944871 — LMD GIARDIA ANTIGEN DETECTION ASSAY (June 22, 1995)
  • K905598 — CRYPTOSPORIDIUM ANTIGEN DETECTION (September 5, 1991)
  • K904613 — TRICHINELLA SEROLOGY MICROTITER ELISA (March 21, 1991)
  • K900780 — CYSTICERCOSIS SEROLOGICAL REAGENTS (October 4, 1990)
  • K890003 — GIARDIA STOOL ANTIGEN TEST KIT (March 14, 1989)
  • K883720 — TREND(R) EMERGE(TM) TOXOPLASMA IGG ELISA (January 24, 1989)
  • K854230 — MEBIASIS AGAR GEL DIFFUSION KIT (November 12, 1985)
  • K854017 — ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT) (October 22, 1985)

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

FDA data resources