Cleared Traditional

CULTURETTE BRAND RAPID LATEX TEST CLOSTRIDIUM TOXI

K852044 · Marion Laboratories, Inc. · Microbiology
Jul 1985
Decision
71d
Days
Class 1
Risk

About This 510(k) Submission

K852044 is an FDA 510(k) clearance for the CULTURETTE BRAND RAPID LATEX TEST CLOSTRIDIUM TOXI, 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 July 19, 1985, 71 days after receiving the submission on May 9, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K852044 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 1985
Decision Date July 19, 1985
Days to Decision 71 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