LJP · Class I · 21 CFR 866.3120

FDA Product Code LJP: Antiserum, Fluorescent, Chlamydia Trachomatis

Leading manufacturers include Syva Co., Syncor Intl. Corp. and Orion Corp..

35
Total
35
Cleared
86d
Avg days
1982
Since

FDA 510(k) Cleared Antiserum, Fluorescent, Chlamydia Trachomatis Devices (Product Code LJP)

35 devices
1–24 of 35
Cleared Sep 24, 2007
DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT
K063675
Diagnostic Hybrids, Inc.
Microbiology · 287d
Cleared Jul 18, 1994
CHLAMYDIA TRACHOMATIS ANTIGEN TEST
K941714
Neogenex
Microbiology · 117d
Cleared Apr 16, 1990
PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST
K900870
Diagnostic Products Corp.
Microbiology · 51d
Cleared Feb 01, 1990
PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1
K895839
Diagnostic Products Corp.
Microbiology · 121d
Cleared Oct 06, 1988
FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI
K883352
Whittaker Bioproducts, Inc.
Microbiology · 58d
Cleared Apr 27, 1988
ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST
K881500
Ortho Diagnostic Systems, Inc.
Microbiology · 16d
Cleared Mar 17, 1988
PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS
K880031
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 72d
Cleared Sep 22, 1987
MODIFIED CHLAMYSET ANTIGEN
K872744
Orion Corp.
Microbiology · 74d
Cleared Aug 06, 1987
MICROTRAK CHLAMYDIA TRACHO. TEST - METHANOL FIXAT.
K872903
Syva Co.
Microbiology · 10d
Cleared Apr 29, 1987
CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT
K864128
Diagnostic Technology, Inc.
Microbiology · 190d
Cleared Apr 29, 1987
MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST
K870946
Serono Diagnostics, Inc.
Microbiology · 51d
Cleared Mar 25, 1987
CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS
K864662
American Micro Scan
Microbiology · 117d
Cleared Mar 12, 1987
MODIFIED IMAGEN(TM) CHLAMYDIA TEST
K864539
Boots-Celltech Diagnostics, Inc.
Microbiology · 113d
Cleared Feb 25, 1987
MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT SPECI. TEST
K864888
Syva Co.
Microbiology · 75d
Cleared Feb 02, 1987
PATHFINDER CHLAMYDIA CULTURE CONFIRMATION SYSTEM
K864663
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 66d
Cleared Dec 04, 1986
CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST
K864389
American Micro Scan
Microbiology · 28d
Cleared Dec 03, 1986
PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM
K863681
Kallestad Laboratories, Inc.
Microbiology · 75d
Cleared Aug 19, 1986
DIFCO CHLAMYDIA DIRECT DETECTION SYSTEM
K862320
Difco Laboratories, Inc.
Microbiology · 62d
Cleared Apr 28, 1986
CHLAMYSET ANTIGEN
K853401
Orion Corp.
Microbiology · 259d
Cleared Mar 10, 1986
CELLMATICS CHLAMYDIA MONOCLONAL DFA REAGENT
K860179
Difco Laboratories, Inc.
Microbiology · 52d
Cleared Dec 06, 1985
ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST
K853738
Ortho Diagnostic Systems, Inc.
Microbiology · 91d
Cleared Sep 16, 1985
MICROTRAK CHLAMYDIA TRACHOMATIS DIR SPECIMEN TEST
K852779
Syva Co.
Microbiology · 77d
Cleared Jun 21, 1985
SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT
K851033
Syncor Intl. Corp.
Microbiology · 101d
Cleared Mar 21, 1985
CHLAMYDIA FLUORO-KIT 1680
K850158
Clinical Sciences, Inc.
Microbiology · 65d

About Product Code LJP - Regulatory Context