Atlas FDA

LJP

35 FDA 510(k) clearances · Product code

75 daysmedian time to decision
121 days90th percentile
35clearances measured

FDA profile

Official device name
Antiserum, Fluorescent, Chlamydia Trachomatis
Device class
Class I (low risk)
Regulation
21 CFR 866.3120
Medical specialty
Microbiology
Flags
Third-party review eligible
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RecordFirmDate
DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT (K063675)Diagnostic Hybrids, Inc.2007-09-24
CHLAMYDIA TRACHOMATIS ANTIGEN TEST (K941714)Neogenex1994-07-18
CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST (K901243)Cel Labs Pty, Ltd.1990-05-21
PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST (K900870)Diagnostic Products Corp.1990-04-16
PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1 (K895839)Diagnostic Products Corp.1990-02-01
FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI (K883352)Whittaker Bioproducts, Inc.1988-10-06
ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST (K881500)Ortho Diagnostic Systems, Inc.1988-04-27
PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS (K880031)Kallestad Diag, A Div. of Erbamont, Inc.1988-03-17
MODIFIED CHLAMYSET ANTIGEN (K872744)Orion Corp.1987-09-22
MICROTRAK CHLAMYDIA TRACHO. TEST - METHANOL FIXAT. (K872903)Syva Co.1987-08-06
MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST (K870946)Serono Diagnostics, Inc.1987-04-29
CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT (K864128)Diagnostic Technology, Inc.1987-04-29
MODIFIED CHLAMYDIA DIRECT SPECIMEN TEST KIT (K871278)California Integrated Diagnostics, Inc.1987-04-08
CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS (K864662)American Micro Scan1987-03-25
MODIFIED IMAGEN(TM) CHLAMYDIA TEST (K864539)Boots-Celltech Diagnostics, Inc.1987-03-12
MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT SPECI. TEST (K864888)Syva Co.1987-02-25
PATHFINDER CHLAMYDIA CULTURE CONFIRMATION SYSTEM (K864663)Kallestad Diag, A Div. of Erbamont, Inc.1987-02-02
CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST (K864389)American Micro Scan1986-12-04
PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM (K863681)Kallestad Laboratories, Inc.1986-12-03
MONOFLUOR CHLAMYDIA TRACHOMATIS DIR SPEC TEST KIT (K862354)Synbiotics Corp.1986-09-29
DIFCO CHLAMYDIA DIRECT DETECTION SYSTEM (K862320)Difco Laboratories, Inc.1986-08-19
CHLAMYSET ANTIGEN (K853401)Orion Corp.1986-04-28
CELLMATICS CHLAMYDIA MONOCLONAL DFA REAGENT (K860179)Difco Laboratories, Inc.1986-03-10
ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST (K853738)Ortho Diagnostic Systems, Inc.1985-12-06
MICROTRAK CHLAMYDIA TRACHOMATIS DIR SPECIMEN TEST (K852779)Syva Co.1985-09-16
SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT (K851033)Syncor Intl. Corp.1985-06-21
CHLAMYDIA FLUORO-KIT 1680 (K850158)Clinical Sciences, Inc.1985-03-21
SYNCOR TECH CHLAMYDIA TISSUE CULTURE TEST (K844582)Syncor Intl. Corp.1985-01-16
AMIZYME-C TRACHOMATIS TEST KIT (K842525)Amico Lab, Inc.1984-10-01
ANTI-CHLAMYDIA TRACHOMATIS KIT (K842658)Amico Lab, Inc.1984-10-01
MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT (K842623)Syva Co.1984-08-02
ADP IFA TEST FOR CHLAMYDIAE TRACHOMATIS (K834242)Apple Diagnostic Products1984-03-02
MICRO TRAK CHLAMYDIA TRAC CONTROL SLID (K832078)Syva Co.1983-09-29
MICRO TRAK CHLAMYDIA TRACHOMATIS DIRECT (K832077)Syva Co.1983-09-29
MICRO TRAK CHLAMYDIA TRACHOMATIS CULT (K823010)Syva Co.1982-12-15

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Every clearance here is in the API, with alerts when new ones post.