Cleared Traditional

K870864 - CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST
(FDA 510(k) Clearance)

K870864 · Marion Laboratories, Inc. · Microbiology device

Apr 1987

Decision

42d

Days

Class 1

Risk

K870864 is an FDA 510(k) clearance for the CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST. This device is classified as 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 April 14, 1987, 42 days after receiving the submission on March 3, 1987.

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

Submission Details

510(k) Number	K870864 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 03, 1987
Decision Date	April 14, 1987
Days to Decision	42 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—