Cleared Traditional

K841219 - SHOPPED MEAT CARBOHYDRATE (FDA 510(k) Clearance)

K841219 · Anaerobe Systems · Microbiology device

Apr 1984

Decision

13d

Days

Class 1

Risk

K841219 is an FDA 510(k) clearance for the SHOPPED MEAT CARBOHYDRATE. This device is classified as a Culture Media, General Nutrient Broth (Class I - General Controls, product code JSC).

Submitted by Anaerobe Systems (Mchenry, US). The FDA issued a Cleared decision on April 4, 1984, 13 days after receiving the submission on March 22, 1984.

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

Submission Details

510(k) Number	K841219 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 22, 1984
Decision Date	April 04, 1984
Days to Decision	13 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—