Atlas FDA

JXA

44 FDA 510(k) clearances · Product code

61 daysmedian time to decision
208 days90th percentile
44clearances measured

FDA profile

Official device name
Kit, Screening, Urine
Device class
Class I (low risk)
Regulation
21 CFR 866.2660
Medical specialty
Microbiology
Adverse events (MAUDE)
1998: 1 · 1999: 1 · 2001: 2 · 2015: 8 · 2016: 9 · 2020: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI) (K011043)Osmetech2001-11-30
URISCREEN (K981084)Diatech Diagnostics,Inc.1998-10-07
URINE SCREENING DEVICE (K972676)Combact Diagnostic Systems , Ltd.1998-02-23
TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT (K952246)Tri-Tech, Inc.1995-06-20
MULTIPLE (IZON DBS & URINE COLLECTION KIT) (K950257)Izon Business Products, Inc.1995-04-14
MULTIPLE (IZON BLOOD & URINE COLLECTION KIT) (K950221)Izon Business Products, Inc.1995-03-21
MULTIPLE (IZON URINE COLLECTION KIT) (K950246)Izon Business Products, Inc.1995-03-21
CULTURIA MACCONKEY-MUG (K934759)Clinical Convenience Products, Inc.1994-09-09
BAC-T-SCREEN (K924218)Biomerieux Vitek, Inc.1993-02-03
DIASLIDE URINE CULTURING DEVICE (K921045)Savyon Diagnostics , Ltd.1992-09-28
URI-THREE(TM), MODIFICATION (K911846)Culture Kits, Inc.1991-10-04
QUALTURE (K903470)Future Medical Technologies Intl., Inc.1990-12-13
RAPIDEC UR (K894805)Dms Products, Inc.1989-09-26
GEN-PROBE PACE SYSTEM URINE SCREEN (K892216)Gen-Probe, Inc.1989-09-15
URISCREEN (K882211)Diatech Diagnostica , Ltd.1988-09-30
RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST (K883385)Los Alamos Diagnostics1988-09-07
MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEM (K881439)Los Alamos Diagnostics1988-04-28
ROUND 1 (K873086)Bioclinical Systems, Inc.1987-08-24
LYFO KWIK(TM) RUS KIT (K870731)Micro-Bio-Logics1987-06-17
N-D URINE TUBE SYSTEM (N-D TUBE/CAP/PIPETTE) (K864177)Cls Co.1987-02-24
UTISCREEN(R) BACTERIAL ATP TEST (K864202)Los Alamos Diagnostics1987-02-13
RAPID BACTERIURIA SCREEN (RBS) (K862195)New Horizons Diagnostics Co.1986-06-30
SLIDE CULTURE U 'EIKEN' (K861631)Syn-Kit, Inc.1986-06-10
URICHECK (K860905)Difco Laboratories, Inc.1986-04-04
FILTRA-CHECK-UTI (K860483)Applied Polytechnology, Inc.1986-04-04
BAC-T-SCREEN (K851399)Marion Laboratories, Inc.1985-06-04
BACTERIURIA DETECT DEVICE, MULTI SAMPLER (K843833)Applied Polytechnology, Inc.1984-11-29
BACTERIURIA DETECT. DEVICE APTEK II (K843834)Applied Polytechnology, Inc.1984-11-29
ORTHO BACTERIURIA DETECTION SYS (K833834)Ortho Diagnostic Systems, Inc.1984-03-12
BACTERUERIA SCREENING PROCEDURE (K832975)Turner Designs, Inc.1983-11-14
DIPCHEX DIP-SLIDE CULTURE SYS (K830252)Granite Diagnostics, Inc.1983-03-07
BAC-T-SCREEN BACTERIURIA DETECTION DEV (K823850)Marion Laboratories, Inc.1983-03-01
RAPID BACTERIURIA SCREENING TEST (K820126)Analytical Luminescence Laboratory, Inc.1983-01-07
LUMAC'S BACTERIURIA SCREENING KIT (K810746)Lumac1981-07-31
URI-DIP (R) (K800626)Pharma-Medica of Scandinavia, Ltd.1980-04-24
CULTURIA MACCONKEY/CLED #DM87 (K800215)Clinical Convenience Products, Inc.1980-02-13
CULTURIA MACCONKEY/COLUMBIA CNA (K792579)Clinical Convenience Products, Inc.1980-01-11
CULTURIA EMB/COLUMBIA CNA W/5% SHEEP (K792284)Clinical Convenience Products, Inc.1979-12-19
MS-2 AUTOMATED URINE SCREENING SYSTEM (K781370)Abbott Laboratories1978-09-20
VAC-U-PAC KIDNEY CASSETTE (K781536)E-Z-Em, Inc.1978-09-14
TILL-U-TEST, DIP SLIDE (K780803)Biotron , Ltd.1978-06-06
URINE SCREENING KITS (K780021)Diagnostic Culture System1978-03-17
TILL-U=TEST (K780109)Clinifax Industries, Ltd.1978-01-31
MICROCULT-ID (K771672)Miles Laboratories, Inc.1977-12-09

Track JXA automatically

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