Cleared Traditional

MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST

K863485 · Marion Laboratories, Inc. · Microbiology
Sep 1986
Decision
8d
Days
Class 1
Risk

About This 510(k) Submission

K863485 is an FDA 510(k) clearance for the MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST, a Reagents, Clostridium Difficile Toxin (Class I — General Controls, product code LLH), submitted by Marion Laboratories, Inc. (Kansas City, US). The FDA issued a Cleared decision on September 17, 1986, 8 days after receiving the submission on September 9, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K863485 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 1986
Decision Date September 17, 1986
Days to Decision 8 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

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