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510(k) K844141

ENTAMOEBA HISTOLYTICA HK-9 ANTIGEN (AXENIC) by Lmd Laboratories — Product Code KHW

K844141 is an FDA 510(k) premarket notification submitted by Lmd Laboratories for the device "ENTAMOEBA HISTOLYTICA HK-9 ANTIGEN (AXENIC)". The FDA issued a decision of Substantially Equivalent on December 6, 1984. 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
December 6, 1984
Date Received
October 23, 1984
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)
  • K870318 — AMEBIASIS ELISA TEST KIT (August 11, 1987)
  • K854230 — MEBIASIS AGAR GEL DIFFUSION KIT (November 12, 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)
  • K870318 — AMEBIASIS ELISA TEST KIT (August 11, 1987)

FDA data resources