Cleared Traditional

K881502 - BREWER GEL FOR CAMPYLOBACTER
(FDA 510(k) Clearance)

K881502 · Fairleigh Dickinson Laboratories, Inc. · Microbiology

Apr 1988

Decision

16d

Days

Class 1

Risk

K881502 is an FDA 510(k) clearance for the BREWER GEL FOR CAMPYLOBACTER, a Device, Gas Generating (Class I — General Controls, product code KZJ), submitted by Fairleigh Dickinson Laboratories, Inc. (Abilene, US). The FDA issued a Cleared decision on April 27, 1988, 16 days after receiving the submission on April 11, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2580.

Submission Details

510(k) Number	K881502 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 11, 1988
Decision Date	April 27, 1988
Days to Decision	16 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—