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 Ortho Diagnostic Systems, Inc..

67
Total
67
Cleared
145d
Avg days
1982
Since

FDA 510(k) Cleared Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) Devices (Product Code LJC)

67 devices
1–24 of 67
Cleared Jul 09, 1998
MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA
K982210
Dade Behring, Inc.
Microbiology · 16d
Cleared Feb 24, 1997
CHLAMYDIA IGG ELISA TEST SYSTEM
K962558
Armkel, LLC
Microbiology · 238d
Cleared Feb 04, 1997
ACCESS CHLAMYDIA ASSAY
K960850
Bio-Rad Laboratories, Inc.
Microbiology · 340d
Cleared Oct 07, 1996
VIDAS CHLAMYDIA BLOCKING ASSAY
K955627
Biomerieux Vitek, Inc.
Microbiology · 301d
Cleared May 30, 1996
IMX SELECT CHLAMYDIA
K936054
Abbott Laboratories
Microbiology · 891d
Cleared May 19, 1995
ACCESS(R) CHLAMYDIA EIA AND BLOCKING ASSAY
K935807
Bio-Rad Laboratories, Inc.
Microbiology · 533d
Cleared May 19, 1995
QUICKVUE(R) CHLAMYDIA TEST
K946276
Quidel Corp.
Microbiology · 147d
Cleared Sep 20, 1994
CHLAMYDIA MICROPLATE EIA, CHLAMYDIA MICROPLAE EIA BLOCKING ASSAY
K935393
Bio-Rad Laboratories, Inc.
Microbiology · 316d
Cleared Sep 30, 1993
SYVA MICROTRAK(R) II CHLAMYDIA EIA BLOCK REAGENT
K926090
Syva Co.
Microbiology · 302d
Cleared Oct 01, 1992
MICRO TRAK XL SYSTEM
K921747
Syva Co.
Microbiology · 171d
Cleared Sep 25, 1992
SYVA MICROTRAK CHLAMYDIA EIA
K920503
Syva Co.
Microbiology · 233d
Cleared Sep 25, 1992
MICROTRAK(R) II CHLAMYDIA EIA ASSAY
K921462
Syva Co.
Microbiology · 182d
Cleared Aug 11, 1992
ORTHO CHLAMYDIA ANTIGEN ELISA TEST
K921321
Ortho Diagnostic Systems, Inc.
Microbiology · 148d
Cleared Mar 04, 1992
VIDAS CHLAMYDIA ASSAY, MODIFICATION
K915884
Vitek Systems, Inc.
Microbiology · 83d
Cleared Jul 22, 1991
ANTIGENZ CHLAMYDIA
K912680
Baxter Diagnostics, Inc.
Microbiology · 49d
Cleared Apr 29, 1991
VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST
K905787
Vitek Systems, Inc.
Microbiology · 123d
Cleared Mar 27, 1991
CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY
K904189
Ciba Corning Diagnostics Corp.
Microbiology · 196d
Cleared Mar 19, 1991
ORTHO* CHLAMYDIA ANTIGEN ELISA TEST/MODIFICATION
K910668
Ortho Diagnostic Systems, Inc.
Microbiology · 34d
Cleared Mar 12, 1991
SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION
K905179
Syva Co.
Microbiology · 113d
Cleared Jan 14, 1991
CHLAMYDIA SYSTEM SOFTWARE (CSS)
K904725
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 89d
Cleared Dec 21, 1990
ORTHO CHLAMYDIA ANTIGEN ELISA/ELISA CULT EXTRA BUF
K903132
Ortho Diagnostic Systems, Inc.
Microbiology · 157d
Cleared Oct 02, 1990
QUIDEL CHLAMYDIA POSITIVE CONTROL
K903765
Quidel Corp.
Microbiology · 46d
Cleared Sep 12, 1990
SYVA MICROTRAK EIA ACCESSORY REAGENTS
K903758
Syva Co.
Microbiology · 23d
Cleared Jul 31, 1990
CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY
K902270
Ciba Corning Diagnostics Corp.
Microbiology · 71d

About Product Code LJC - Regulatory Context