Cleared Traditional

COLUMBIA BLOOD AGAR WITH 5% SHEEP BLOOD

K864240 · Mds Laboratories, Inc. · Microbiology
Mar 1987
Decision
154d
Days
Class 1
Risk

About This 510(k) Submission

K864240 is an FDA 510(k) clearance for the COLUMBIA BLOOD AGAR WITH 5% SHEEP BLOOD, a Culture Media, Non-selective And Non-differential (Class I — General Controls, product code JSG), submitted by Mds Laboratories, Inc. (L5j 2m4, CA). The FDA issued a Cleared decision on March 31, 1987, 154 days after receiving the submission on October 28, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2300.

Submission Details

510(k) Number K864240 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 1986
Decision Date March 31, 1987
Days to Decision 154 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