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 Eastman Kodak Company.

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 Mar 02, 2004
CT OIA
K032330
Thermo Biostar, Inc.
Microbiology · 217d
Cleared Jan 21, 2004
IDEIA PCE CHLAMYDIA
K033865
Dakocytomation, Ltd.
Microbiology · 40d
Cleared Nov 26, 2003
CHLAMYDIA IGG ELISA TEST SYSTEM
K033079
Trinity Biotech USA
Microbiology · 58d
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 Jan 11, 1996
IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION
K940564
Dako Diagnostics , Ltd.
Microbiology · 707d
Cleared Oct 07, 1995
CHLAMYDIA OIA
K951010
Biostar, Inc.
Microbiology · 215d
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 Jun 09, 1992
SEROELISA(TM) CHLAMYDIA IGA TEST KIT
K914327
Savyon Diagnostics , Ltd.
Microbiology · 256d
Cleared Mar 23, 1992
SEROLISA CHLAMYDIA IGG TEST KIT
K915281
Savyon Diagnostics , Ltd.
Microbiology · 119d
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

About Product Code LJC - Regulatory Context