JXA · Class I · 21 CFR 866.2660

FDA Product Code JXA: Kit, Screening, Urine

Leading manufacturers include Clinical Convenience Products, Inc., Applied Polytechnology, Inc. and Los Alamos Diagnostics.

44
Total
44
Cleared
95d
Avg days
1977
Since

FDA 510(k) Cleared Kit, Screening, Urine Devices (Product Code JXA)

44 devices
1–24 of 44
Cleared Nov 30, 2001
OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)
K011043
Osmetech
Microbiology · 239d
Cleared Oct 07, 1998
URISCREEN
K981084
Diatech Diagnostics,Inc.
Microbiology · 196d
Cleared Feb 23, 1998
URINE SCREENING DEVICE
K972676
Combact Diagnostic Systems , Ltd.
Microbiology · 222d
Cleared Jun 20, 1995
TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT
K952246
Tri-Tech, Inc.
Chemistry · 39d
Cleared Apr 14, 1995
MULTIPLE (IZON DBS & URINE COLLECTION KIT)
K950257
Izon Business Products, Inc.
Chemistry · 81d
Cleared Mar 21, 1995
MULTIPLE (IZON BLOOD & URINE COLLECTION KIT)
K950221
Izon Business Products, Inc.
Chemistry · 61d
Cleared Mar 21, 1995
MULTIPLE (IZON URINE COLLECTION KIT)
K950246
Izon Business Products, Inc.
Chemistry · 60d
Cleared Sep 09, 1994
CULTURIA MACCONKEY-MUG
K934759
Clinical Convenience Products, Inc.
Microbiology · 340d
Cleared Feb 03, 1993
BAC-T-SCREEN
K924218
Biomerieux Vitek, Inc.
Microbiology · 167d
Cleared Sep 28, 1992
DIASLIDE URINE CULTURING DEVICE
K921045
Savyon Diagnostics , Ltd.
Microbiology · 208d
Cleared Oct 04, 1991
URI-THREE(TM), MODIFICATION
K911846
Culture Kits, Inc.
Microbiology · 169d
Cleared Dec 13, 1990
QUALTURE
K903470
Future Medical Technologies Intl., Inc.
Microbiology · 134d
Cleared Sep 26, 1989
RAPIDEC UR
K894805
Dms Products, Inc.
Microbiology · 60d
Cleared Sep 15, 1989
GEN-PROBE PACE SYSTEM URINE SCREEN
K892216
Gen-Probe, Inc.
Microbiology · 165d
Cleared Sep 30, 1988
URISCREEN
K882211
Diatech Diagnostica , Ltd.
Microbiology · 127d
Cleared Sep 07, 1988
RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST
K883385
Los Alamos Diagnostics
Microbiology · 29d
Cleared Apr 28, 1988
MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEM
K881439
Los Alamos Diagnostics
Microbiology · 23d
Cleared Aug 24, 1987
ROUND 1
K873086
Bioclinical Systems, Inc.
Microbiology · 18d
Cleared Jun 17, 1987
LYFO KWIK(TM) RUS KIT
K870731
Micro-Bio-Logics
Microbiology · 112d
Cleared Feb 24, 1987
N-D URINE TUBE SYSTEM (N-D TUBE/CAP/PIPETTE)
K864177
Cls Co.
Hematology · 123d
Cleared Feb 13, 1987
UTISCREEN(R) BACTERIAL ATP TEST
K864202
Los Alamos Diagnostics
Microbiology · 109d
Cleared Jun 30, 1986
RAPID BACTERIURIA SCREEN (RBS)
K862195
New Horizons Diagnostics Co.
Microbiology · 21d
Cleared Jun 10, 1986
SLIDE CULTURE U 'EIKEN'
K861631
Syn-Kit, Inc.
Microbiology · 42d
Cleared Apr 04, 1986
FILTRA-CHECK-UTI
K860483
Applied Polytechnology, Inc.
Microbiology · 53d

About Product Code JXA - Regulatory Context