ClearanceBrief
Panels › Microbiology › Product code JXA · Class 1

Kit, Screening, Urine

Regulation 866.2660

0510(k)s in 12 months (44 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in JXA

Company510(k)sRecalls
Clinical Convenience Products, Inc.40
Applied Polytechnology, Inc.30
Izon Business Products, Inc.30
Los Alamos Diagnostics30
Marion Laboratories, Inc.20
Abbott Laboratories10
Analytical Luminescence Laboratory, Inc.10
Bioclinical Systems, Inc.10
Biomerieux Vitek, Inc.10
Biotron , Ltd.10
Decided510(k)Device and applicantCode
Nov 30, 2001K011043OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)
Osmetech, GB
JXA
Oct 7, 1998K981084URISCREEN
Diatech Diagnostics,Inc.
JXA
Feb 23, 1998K972676URINE SCREENING DEVICE
Combact Diagnostic Systems , Ltd.
JXA
Jun 20, 1995K952246TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT
Tri-Tech, Inc.
JXA
Apr 14, 1995K950257MULTIPLE (IZON DBS & URINE COLLECTION KIT)
Izon Business Products, Inc.
JXA
Mar 21, 1995K950246MULTIPLE (IZON URINE COLLECTION KIT)
Izon Business Products, Inc.
JXA
Mar 21, 1995K950221MULTIPLE (IZON BLOOD & URINE COLLECTION KIT)
Izon Business Products, Inc.
JXA
Sep 9, 1994K934759CULTURIA MACCONKEY-MUG
Clinical Convenience Products, Inc.
JXA
Feb 3, 1993K924218BAC-T-SCREEN
Biomerieux Vitek, Inc.
JXA
Sep 28, 1992K921045DIASLIDE URINE CULTURING DEVICE
Savyon Diagnostics , Ltd., IL
JXA
Oct 4, 1991K911846URI-THREE(TM), MODIFICATION
Culture Kits, Inc.
JXA
Dec 13, 1990K903470QUALTURE
Future Medical Technologies Intl., Inc.
JXA
Sep 26, 1989K894805RAPIDEC UR
Dms Products, Inc.
JXA
Sep 15, 1989K892216GEN-PROBE PACE SYSTEM URINE SCREEN
Gen-Probe, Inc.
JXA
Sep 30, 1988K882211URISCREEN
Diatech Diagnostica , Ltd.
JXA
Sep 7, 1988K883385RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST
Los Alamos Diagnostics
JXA
Apr 28, 1988K881439MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEM
Los Alamos Diagnostics
JXA
Aug 24, 1987K873086ROUND 1
Bioclinical Systems, Inc.
JXA
Jun 17, 1987K870731LYFO KWIK(TM) RUS KIT
Micro-Bio-Logics
JXA
Feb 24, 1987K864177N-D URINE TUBE SYSTEM (N-D TUBE/CAP/PIPETTE)
Cls Co.
JXA
Feb 13, 1987K864202UTISCREEN(R) BACTERIAL ATP TEST
Los Alamos Diagnostics
JXA
Jun 30, 1986K862195RAPID BACTERIURIA SCREEN (RBS)
New Horizons Diagnostics Co.
JXA
Jun 10, 1986K861631SLIDE CULTURE U 'EIKEN'
Syn-Kit, Inc.
JXA
Apr 4, 1986K860905URICHECK
Difco Laboratories, Inc.
JXA
Apr 4, 1986K860483FILTRA-CHECK-UTI
Applied Polytechnology, Inc.
JXA
Jun 4, 1985K851399BAC-T-SCREEN
Marion Laboratories, Inc.
JXA
Nov 29, 1984K843834BACTERIURIA DETECT. DEVICE APTEK II
Applied Polytechnology, Inc.
JXA
Nov 29, 1984K843833BACTERIURIA DETECT DEVICE, MULTI SAMPLER
Applied Polytechnology, Inc.
JXA
Mar 12, 1984K833834ORTHO BACTERIURIA DETECTION SYS
Ortho Diagnostic Systems, Inc.
JXA
Nov 14, 1983K832975BACTERUERIA SCREENING PROCEDURE
Turner Designs, Inc.
JXA
Mar 7, 1983K830252DIPCHEX DIP-SLIDE CULTURE SYS
Granite Diagnostics, Inc.
JXA
Mar 1, 1983K823850BAC-T-SCREEN BACTERIURIA DETECTION DEV
Marion Laboratories, Inc.
JXA
Jan 7, 1983K820126RAPID BACTERIURIA SCREENING TEST
Analytical Luminescence Laboratory, Inc.
JXA
Jul 31, 1981K810746LUMAC'S BACTERIURIA SCREENING KIT
Lumac
JXA
Apr 24, 1980K800626URI-DIP (R)
Pharma-Medica of Scandinavia, Ltd.
JXA
Feb 13, 1980K800215CULTURIA MACCONKEY/CLED #DM87
Clinical Convenience Products, Inc.
JXA
Jan 11, 1980K792579CULTURIA MACCONKEY/COLUMBIA CNA
Clinical Convenience Products, Inc.
JXA
Dec 19, 1979K792284CULTURIA EMB/COLUMBIA CNA W/5% SHEEP
Clinical Convenience Products, Inc.
JXA
Sep 20, 1978K781370MS-2 AUTOMATED URINE SCREENING SYSTEM
Abbott Laboratories
JXA
Sep 14, 1978K781536VAC-U-PAC KIDNEY CASSETTE
E-Z-Em, Inc.
JXA
Jun 6, 1978K780803TILL-U-TEST, DIP SLIDE
Biotron , Ltd.
JXA
Mar 17, 1978K780021URINE SCREENING KITS
Diagnostic Culture System
JXA
Jan 31, 1978K780109TILL-U=TEST
Clinifax Industries, Ltd.
JXA
Dec 9, 1977K771672MICROCULT-ID
Miles Laboratories, Inc.
JXA

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