LKQ · Class II · 21 CFR 866.3175

FDA Product Code LKQ: Antibody Igm,if, Cytomegalovirus Virus

Leading manufacturers include Behring Diagnostics, Inc., Abbott Laboratories and Zeus Scientific, Inc..

18
Total
18
Cleared
147d
Avg days
1983
Since

FDA 510(k) Cleared Antibody Igm,if, Cytomegalovirus Virus Devices (Product Code LKQ)

18 devices
1–18 of 18
Cleared Apr 26, 1990
CMV-IGM IFA TEST SYSTEM
K900743
Zeus Scientific, Inc.
Microbiology · 69d
Cleared May 13, 1988
ABBOTT CMV-M EIA KIT
K872881
Abbott Laboratories
Microbiology · 296d
Cleared Jul 21, 1986
ENZYGNOST ANTI-CMV IGM TEST
K861363
Behring Diagnostics, Inc.
Microbiology · 102d
Cleared Apr 21, 1986
CORDIA CMV-M
K853889
Cordis Corp.
Microbiology · 214d

About Product Code LKQ - Regulatory Context