Home / 510(k) Clearances / K944871

510(k) K944871

LMD GIARDIA ANTIGEN DETECTION ASSAY by Lmd Laboratories — Product Code MHI

K944871 is an FDA 510(k) premarket notification submitted by Lmd Laboratories for the device "LMD GIARDIA ANTIGEN DETECTION ASSAY". The FDA issued a decision of Substantially Equivalent on June 22, 1995. The device falls under product code MHI (Giardia 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
June 22, 1995
Date Received
October 3, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Giardia 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)
  • 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)
  • K854017 — ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT) (October 22, 1985)

Other clearances for product code MHI

  • K120001 — UNIGOLD GIARDIA (March 1, 2013)
  • K103673 — GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK (August 18, 2011)
  • K081064 — GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF (January 14, 2009)
  • K031942 — XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020 (November 18, 2003)
  • K031834 — XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY (November 10, 2003)
  • K033274 — GIARDIA II (November 4, 2003)
  • K024113 — IVD CRYPTO/GIARDIA DFA (March 5, 2003)
  • K020583 — IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96 (September 17, 2002)
  • K983399 — GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY (January 11, 1999)
  • K982711 — PREMIER GIARDIA (November 25, 1998)

FDA data resources