Cleared Traditional

IMMUNOCARD STAT CAMPY, MODEL 751530

K090700 · Meridian Bioscience, Inc. · Microbiology
May 2009
Decision
72d
Days
Class 1
Risk

About This 510(k) Submission

K090700 is an FDA 510(k) clearance for the IMMUNOCARD STAT CAMPY, MODEL 751530, a Campylobacter Spp. (Class I — General Controls, product code LQP), submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on May 28, 2009, 72 days after receiving the submission on March 17, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number K090700 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 2009
Decision Date May 28, 2009
Days to Decision 72 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LQP — Campylobacter Spp.
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3110