LKA · Class II · 21 CFR 866.1700

FDA Product Code LKA: Culture Media, Antimicrobial Susceptibility Test

Leading manufacturers include I.A.F. Production, Inc. and Acumedia Manufacturers, Inc..

5
Total
5
Cleared
36d
Avg days
1983
Since

FDA 510(k) Cleared Culture Media, Antimicrobial Susceptibility Test Devices (Product Code LKA)

5 devices
1–5 of 5
Cleared Aug 11, 1987
IAFP MUELLER HINTON AGAR
K872686
I.A.F. Production, Inc.
Microbiology · 35d
Cleared Aug 11, 1987
IAFP MUELLER HINTON AGAR W/HEMO. W/CVA ENRICHMENT
K872687
I.A.F. Production, Inc.
Microbiology · 35d
Cleared Aug 11, 1987
IAFP MUELLER HINTON AGAR W/5% SHEEP BLOOD
K872688
I.A.F. Production, Inc.
Microbiology · 35d
Cleared Oct 27, 1983
AK AGAR 2
K833207
Acumedia Manufacturers, Inc.
Microbiology · 38d
Cleared Oct 27, 1983
YEAST BEEF AGAR-ANTIBIOTIC MED.4
K833218
Acumedia Manufacturers, Inc.
Microbiology · 38d

About Product Code LKA - Regulatory Context