IMMUNOCARD STAT! E. COLI O157:H7— 510(k) K990263

Name: FDA 510(k) clearance K990263
Creator: U.S. Food and Drug Administration
Published: 1999-08-09

Substantially Equivalent

Meridian Diagnostics, Inc.

FDA 510(k) clearance K990263 for IMMUNOCARD STAT! E. COLI O157:H7, Substantially Equivalent on 1999-08-09. Applicant: Meridian Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Meridian Diagnostics, Inc.
Product code: Code GMZ
Device class: Class 1
Regulation: 21 CFR 866.3255
Advisory panel: Microbiology
Date received: 1999-01-27
Decision date: 1999-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GMZ

view all

K222829 — Curian® Shiga Toxin2023-04-17
K121364 — SHIGA TOXIN QUIK CHEK2012-10-02
K121411 — SHIGA TOXIN CHEK2012-10-02
K062546 — IMMUNOCARD STAT! EHEC, MODEL 7516302007-02-14
K061889 — BIOSTAR OIA SHIGATOX2006-12-12

More clearances from Meridian Diagnostics, Inc.

view all

K993914 — PREMIER TOXINS A&B, MODEL 6160961999-12-10
K984343 — PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST1999-06-25
K984346 — PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST1999-06-25
K983255 — MODIFICATION TO: PREMIER PLATINUM HPSA1998-12-17
K982764 — PREMIER CRYPTOSPORIDIUM1998-12-03

Data sourced from openFDA. This site is unofficial and independent of the FDA.