Cleared Traditional

K925329 - CULTURETTE BRAND TOXIN CD TEST (FDA 510(k) Clearance)

K925329 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device

Mar 1993

Decision

154d

Days

Class 1

Risk

K925329 is an FDA 510(k) clearance for the CULTURETTE BRAND TOXIN CD TEST. This device is classified as a Reagents, Clostridium Difficile Toxin (Class I - General Controls, product code LLH).

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Columbus, US). The FDA issued a Cleared decision on March 24, 1993, 154 days after receiving the submission on October 21, 1992.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K925329 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 21, 1992
Decision Date	March 24, 1993
Days to Decision	154 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement

Device Classification

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