Cleared Traditional

K884208 - LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)
(FDA 510(k) Clearance)

K884208 · Oxoid U.S.A., Inc. · Microbiology device

Oct 1988

Decision

19d

Days

Class 1

Risk

K884208 is an FDA 510(k) clearance for the LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION). This device is classified as a Culture Media, Enriched (Class I - General Controls, product code KZI).

Submitted by Oxoid U.S.A., Inc. (Columbia, US). The FDA issued a Cleared decision on October 25, 1988, 19 days after receiving the submission on October 6, 1988.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2330.

Submission Details

510(k) Number	K884208 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 06, 1988
Decision Date	October 25, 1988
Days to Decision	19 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—