LKI · Class I · 21 CFR 866.3120

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

Leading manufacturers include Immulok, Inc., Serono Diagnostics, Inc. and Btc Corp..

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 Feb 19, 1992
IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY
K914953
Stellar Bio Systems, Inc.
Microbiology · 106d
Cleared Jan 25, 1991
LUPUS(LE)-LATEX TEST
K905531
Immco Diagnostics, Inc.
Immunology · 46d
Cleared Aug 15, 1989
CHLAMYDIA (LGV-1)
K894625
Bion Ent., Ltd.
Microbiology · 26d
Cleared Feb 03, 1989
BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE
K883776
Btc Corp.
Microbiology · 150d
Cleared Jan 28, 1986
MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES
K854615
Serono Diagnostics, Inc.
Microbiology · 71d
Cleared May 04, 1983
CULUTURE SET CHLAMYDIA ISOLATION AND
K830342
Immulok, Inc.
Microbiology · 92d

About Product Code LKI - Regulatory Context