LKI · Class I · 21 CFR 866.3120

FDA Product Code LKI: Antisera, Fluorescent, Chlamydia Spp.

Leading manufacturers include Serono Diagnostics, Inc. and Immco Diagnostics, Inc..

6
Total
6
Cleared
82d
Avg days
1983
Since

FDA 510(k) Cleared Antisera, Fluorescent, Chlamydia Spp. Devices (Product Code LKI)

6 devices
1–6 of 6
Cleared Jan 25, 1991
LUPUS(LE)-LATEX TEST
K905531
Immco Diagnostics, Inc.
Immunology · 46d
Cleared Jan 28, 1986
MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES
K854615
Serono Diagnostics, Inc.
Microbiology · 71d

About Product Code LKI - Regulatory Context