LKT · Class I · 21 CFR 866.3480

FDA Product Code LKT: Respiratory Syncytial Virus, Antigen, Antibody, Ifa

Leading manufacturers include Diagnostic Products Corp. and Abbott Laboratories.

23
Total
23
Cleared
101d
Avg days
1983
Since

FDA 510(k) Cleared Respiratory Syncytial Virus, Antigen, Antibody, Ifa Devices (Product Code LKT)

23 devices
1–23 of 23
Cleared Mar 18, 1999
PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1
K983336
Diagnostic Products Corp.
Microbiology · 176d
Cleared Dec 19, 1994
PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)
K943317
Diagnostic Products Corp.
Microbiology · 161d
Cleared Sep 17, 1985
ABBOTT RSV EIA
K852472
Abbott Laboratories
Microbiology · 98d

About Product Code LKT - Regulatory Context