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 Jul 09, 1998
MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA
K982210
Dade Behring, Inc.
Microbiology · 16d
Cleared May 30, 1996
IMX SELECT CHLAMYDIA
K936054
Abbott Laboratories
Microbiology · 891d
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 Mar 12, 1991
SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION
K905179
Syva Co.
Microbiology · 113d
Cleared Sep 12, 1990
SYVA MICROTRAK EIA ACCESSORY REAGENTS
K903758
Syva Co.
Microbiology · 23d
Cleared Jun 20, 1990
KODAK SURECELL(TM) CHLAMYDIA CONTROL FLUID SET
K901934
Eastman Kodak Company
Microbiology · 51d
Cleared May 03, 1990
CHLAMYDIAZYME DIAGNOSTIC KIT
K900543
Abbott Laboratories
Microbiology · 87d
Cleared Mar 08, 1990
ADD'L USES FOR THE KODAK SURECELL CHLAMYDIA KIT
K900402
Eastman Kodak Company
Microbiology · 38d
Cleared Jan 02, 1990
KODAK SURECELL CHLAMYDIA TEST KIT (ADD'L USES)
K895505
Eastman Kodak Company
Microbiology · 113d
Cleared Jul 25, 1989
ABBOTT TESTPACK CHLAMYDIA
K893676
Abbott Laboratories
Microbiology · 70d
Cleared Jun 02, 1989
CHLAMYDIAZYME BLOCKING REAGENT
K892371
Abbott Laboratories
Microbiology · 57d
Cleared Mar 22, 1989
MICROTRAK CHLAMYDIA EIA
K890196
Syva Co.
Microbiology · 63d
Cleared Dec 16, 1988
CHLAMYDIAZYME/COMMANDER INSTRUMENTATION
K885006
Abbott Laboratories
Microbiology · 14d
Cleared Nov 10, 1988
KODAK SURECELL CHLAMYDIA TEST KIT
K882923
Eastman Kodak Company
Microbiology · 120d
Cleared Jul 25, 1988
ABBOTT TESTPACK CHLAMYDIA
K880783
Abbott Laboratories
Microbiology · 150d
Cleared Jul 14, 1988
ABBOTT TESTPACK(TM) CHLAMYDIA POSITIVE CONTROL
K882535
Abbott Laboratories
Microbiology · 23d
Cleared May 23, 1988
CHLAMYDIAZYME(TM)
K880469
Abbott Laboratories
Microbiology · 110d
Cleared Apr 29, 1987
CHLAMYDIAZYME DIAGNOSTIC KIT
K864842
Abbott Laboratories
Microbiology · 140d
Cleared Oct 05, 1983
CHLAMYDIAZYME, ENZYME IMMUNOASSAY DETEC
K831962
Abbott Laboratories
Chemistry · 110d

About Product Code LJC - Regulatory Context