Cleared Traditional

K090700 - IMMUNOCARD STAT CAMPY, MODEL 751530 (FDA 510(k) Clearance)

K090700 · Meridian Bioscience, Inc. · Microbiology device

May 2009

Decision

72d

Days

Class 1

Risk

K090700 is an FDA 510(k) clearance for the IMMUNOCARD STAT CAMPY, MODEL 751530. 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 May 28, 2009, 72 days after receiving the submission on March 17, 2009.

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

Submission Details

510(k) Number	K090700 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 17, 2009
Decision Date	May 28, 2009
Days to Decision	72 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF