Cleared Traditional

TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A

K974881 · Biosite Incorporated · Microbiology
Mar 1998
Decision
80d
Days
Class 1
Risk

About This 510(k) Submission

K974881 is an FDA 510(k) clearance for the TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A, a Antigen, C. Difficile (Class I — General Controls, product code MCB), submitted by Biosite Incorporated (San Diego, US). The FDA issued a Cleared decision on March 20, 1998, 80 days after receiving the submission on December 30, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K974881 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 1997
Decision Date March 20, 1998
Days to Decision 80 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code MCB — Antigen, C. Difficile
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660