Cleared Traditional

K083464 - PREMIER CAMPY, MODEL 618096 (FDA 510(k) Clearance)

K083464 · Meridian Bioscience, Inc. · Microbiology device

Jan 2009

Decision

67d

Days

Class 1

Risk

K083464 is an FDA 510(k) clearance for the PREMIER CAMPY, MODEL 618096. This device is classified as a Campylobacter Spp. (Class I - General Controls, product code LQP).

Submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on January 30, 2009, 67 days after receiving the submission on November 24, 2008.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number	K083464 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 24, 2008
Decision Date	January 30, 2009
Days to Decision	67 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF