LJC · Class I · 21 CFR 866.3120

FDA Product Code LJC: Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group)

Leading manufacturers include Abbott Laboratories, Syva Co. and Kallestad Diag, A Div. of Erbamont, Inc..

67
Total
67
Cleared
145d
Avg days
1982
Since
67 devices
49–67 of 67
Cleared Apr 29, 1987
CHLAMYDIAZYME DIAGNOSTIC KIT
K864842
Abbott Laboratories
Microbiology · 140d
Cleared Nov 05, 1986
ORTHO* CHLAMYDIA ANTIGEN ELISA TEST & TRANSPORT
K863490
Ortho Diagnostic Systems, Inc.
Microbiology · 57d
Cleared Aug 26, 1986
VISIBLE-CHLAMYDIA(TM) TEST SYSTEM
K862638
Isolab, Inc.
Microbiology · 47d
Cleared Aug 19, 1986
MODIFIED IDEIA CHLAMYDIA TEST
K861966
Boots-Celltech Diagnostics, Inc.
Microbiology · 91d
Cleared Oct 05, 1983
CHLAMYDIAZYME, ENZYME IMMUNOASSAY DETEC
K831962
Abbott Laboratories
Chemistry · 110d