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510(k) K942705

E. COLI 0157 ELISA STOOL ASSAY by Lmd Laboratories — Product Code GMZ

K942705 is an FDA 510(k) premarket notification submitted by Lmd Laboratories for the device "E. COLI 0157 ELISA STOOL ASSAY". The FDA issued a decision of Substantially Equivalent on September 27, 1995. The device falls under product code GMZ (Antigens, All Types, Escherichia Coli), a Class I device regulated under 21 CFR 866.3255. Lmd Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1995
Date Received
June 8, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, All Types, Escherichia Coli
Device Class
Class I
Regulation Number
866.3255
Review Panel
MI
Submission Type

Other clearances by Lmd Laboratories

  • K955345 — LMD CRYPTOSPORIDIUM ANTIGEN DETECTION (June 7, 1996)
  • 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)
  • K854017 — ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT) (October 22, 1985)

Other clearances for product code GMZ

  • K222829 — Curian® Shiga Toxin (April 17, 2023)
  • K121411 — SHIGA TOXIN CHEK (October 2, 2012)
  • K121364 — SHIGA TOXIN QUIK CHEK (October 2, 2012)
  • K062546 — IMMUNOCARD STAT! EHEC, MODEL 751630 (February 14, 2007)
  • K061889 — BIOSTAR OIA SHIGATOX (December 12, 2006)
  • K023599 — IMMUNOCARD STAT! E. COLI O157 PLUS (January 3, 2003)
  • K990263 — IMMUNOCARD STAT! E. COLI O157:H7 (August 9, 1999)
  • K980507 — PROSPECT SHIGA TOXIN MICROPLATE ASSAY (April 23, 1998)
  • K973457 — CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800 (January 2, 1998)
  • K971663 — WELLCOLEX E.COLI O157:H7 (December 30, 1997)

FDA data resources