MERITEC C. DIFFICILE CONTROLS— 510(k) K924062

Name: FDA 510(k) clearance K924062
Creator: U.S. Food and Drug Administration
Published: 1992-10-19

Substantially Equivalent

Meridian Diagnostics, Inc.

FDA 510(k) clearance K924062 for MERITEC C. DIFFICILE CONTROLS, Substantially Equivalent on 1992-10-19. Applicant: Meridian Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Meridian Diagnostics, Inc.
Product code: Code MCB
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1992-08-12
Decision date: 1992-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MCB

view all

K132010 — VIDAS C DIFFICILE GDH2013-10-09
K112048 — IMMUNOCARD C. DIFFICILE GDH2011-12-16
K110620 — PREMIER C. DIFFICILE GDH2011-05-03
K053572 — C. DIFF QUIK CHEK2006-04-26
K974881 — TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A1998-03-20

More clearances from Meridian Diagnostics, Inc.

view all

K993914 — PREMIER TOXINS A&B, MODEL 6160961999-12-10
K990263 — IMMUNOCARD STAT! E. COLI O157:H71999-08-09
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

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