Cleared Traditional

K832569 - INFUSION BROTH
(FDA 510(k) Clearance)

K832569 · Acumedia Manufacturers, Inc. · Microbiology device

Sep 1983

Decision

41d

Days

Class 1

Risk

K832569 is an FDA 510(k) clearance for the INFUSION BROTH. This device is classified as a Culture Media, General Nutrient Broth (Class I - General Controls, product code JSC).

Submitted by Acumedia Manufacturers, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983, 41 days after receiving the submission on August 2, 1983.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2350.

Submission Details

510(k) Number	K832569 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 02, 1983
Decision Date	September 12, 1983
Days to Decision	41 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—