Cleared Traditional

COLORPAC TOXIN A

K980185 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology
Jul 1998
Decision
178d
Days
Class 1
Risk

About This 510(k) Submission

K980185 is an FDA 510(k) clearance for the COLORPAC TOXIN A, a Reagents, Clostridium Difficile Toxin (Class I — General Controls, product code LLH), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Sparks, US). The FDA issued a Cleared decision on July 17, 1998, 178 days after receiving the submission on January 20, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K980185 FDA.gov
FDA Decision Cleared SESE
Date Received January 20, 1998
Decision Date July 17, 1998
Days to Decision 178 days
Submission Type Traditional
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