Cleared Traditional

MALT EXTRACT

K881545 · Acumedia Manufacturers, Inc. · Microbiology
Apr 1988
Decision
10d
Days
Class 1
Risk

About This 510(k) Submission

K881545 is an FDA 510(k) clearance for the MALT EXTRACT, a Culture Media, Non-selective And Non-differential (Class I — General Controls, product code JSG), submitted by Acumedia Manufacturers, Inc. (Baltimore, US). The FDA issued a Cleared decision on April 18, 1988, 10 days after receiving the submission on April 8, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2300.

Submission Details

510(k) Number K881545 FDA.gov
FDA Decision Cleared SESE
Date Received April 08, 1988
Decision Date April 18, 1988
Days to Decision 10 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JSG — Culture Media, Non-selective And Non-differential
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2300

Similar Devices — JSG Culture Media, Non-selective And Non-differential

All 208
THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007
K882495 · Lakewood Biochemical Co., Inc. · Jul 1988
DEXTROSE AGAR
K881522 · Acumedia Manufacturers, Inc. · Apr 1988
DEXTROSE TRYPTONE BROTH
K881523 · Acumedia Manufacturers, Inc. · Apr 1988
COOKED MEAT MEDIUM
K881525 · Acumedia Manufacturers, Inc. · Apr 1988
CASEIN PEPTONE, LOW VITAMIN
K881528 · Acumedia Manufacturers, Inc. · Apr 1988
BLOOD AGAR BASE, IMPROVED
K881531 · Acumedia Manufacturers, Inc. · Apr 1988