Cleared Special

PREMIER TOXINS A&B, MODEL 616096

K993914 · Meridian Diagnostics, Inc. · Microbiology
Dec 1999
Decision
23d
Days
Class 1
Risk

About This 510(k) Submission

K993914 is an FDA 510(k) clearance for the PREMIER TOXINS A&B, MODEL 616096, a Reagents, Clostridium Difficile Toxin (Class I — General Controls, product code LLH), submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on December 10, 1999, 23 days after receiving the submission on November 17, 1999. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K993914 FDA.gov
FDA Decision Cleared SESE
Date Received November 17, 1999
Decision Date December 10, 1999
Days to Decision 23 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LLH — Reagents, Clostridium Difficile Toxin
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660