Home / 510(k) Clearances / K062546

510(k) K062546

IMMUNOCARD STAT! EHEC, MODEL 751630 by Meridian Bioscience, Inc. — Product Code GMZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2007
Date Received
August 30, 2006
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 Meridian Bioscience, Inc.

  • K243922 — Revogene (March 20, 2025)
  • K230901 — Premier HpSA Flex (619096) (July 3, 2023)
  • K222829 — Curian® Shiga Toxin (April 17, 2023)
  • K222779 — Revogene (January 26, 2023)
  • K220480 — Revogene (July 11, 2022)
  • K210976 — Curian Campy (December 23, 2021)
  • K192817 — Curian HpSA, Curian Analyzer (March 13, 2020)
  • DEN180040 — Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit (November 30, 2018)
  • K182559 — PREMIER Platinum HpSA PLUS (November 5, 2018)
  • K163273 — TRU Legionella (February 21, 2017)

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)
  • 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)
  • K972156 — QUIX RAPID E. COLI O157 STRIP TEST (October 16, 1997)