JXA · Class I · 21 CFR 866.2660

FDA Product Code JXA: Kit, Screening, Urine

Leading manufacturers include Clinical Convenience Products, Inc., Los Alamos Diagnostics and Izon Business Products, Inc..

44
Total
44
Cleared
95d
Avg days
1977
Since
44 devices
25–44 of 44
Cleared Apr 04, 1986
URICHECK
K860905
Difco Laboratories, Inc.
Microbiology · 25d
Cleared Jun 04, 1985
BAC-T-SCREEN
K851399
Marion Laboratories, Inc.
Microbiology · 56d
Cleared Nov 29, 1984
BACTERIURIA DETECT DEVICE, MULTI SAMPLER
K843833
Applied Polytechnology, Inc.
Microbiology · 59d
Cleared Nov 29, 1984
BACTERIURIA DETECT. DEVICE APTEK II
K843834
Applied Polytechnology, Inc.
Microbiology · 59d
Cleared Mar 12, 1984
ORTHO BACTERIURIA DETECTION SYS
K833834
Ortho Diagnostic Systems, Inc.
Immunology · 130d
Cleared Nov 14, 1983
BACTERUERIA SCREENING PROCEDURE
K832975
Turner Designs, Inc.
Microbiology · 74d
Cleared Mar 07, 1983
DIPCHEX DIP-SLIDE CULTURE SYS
K830252
Granite Diagnostics, Inc.
Microbiology · 41d
Cleared Mar 01, 1983
BAC-T-SCREEN BACTERIURIA DETECTION DEV
K823850
Marion Laboratories, Inc.
Microbiology · 70d
Cleared Jan 07, 1983
RAPID BACTERIURIA SCREENING TEST
K820126
Analytical Luminescence Laboratory, Inc.
Microbiology · 354d
Cleared Jul 31, 1981
LUMAC'S BACTERIURIA SCREENING KIT
K810746
Lumac
Toxicology · 134d
Cleared Apr 24, 1980
URI-DIP (R)
K800626
Pharma-Medica of Scandinavia, Ltd.
Microbiology · 36d
Cleared Feb 13, 1980
CULTURIA MACCONKEY/CLED #DM87
K800215
Clinical Convenience Products, Inc.
Microbiology · 9d
Cleared Jan 11, 1980
CULTURIA MACCONKEY/COLUMBIA CNA
K792579
Clinical Convenience Products, Inc.
Microbiology · 28d
Cleared Dec 19, 1979
CULTURIA EMB/COLUMBIA CNA W/5% SHEEP
K792284
Clinical Convenience Products, Inc.
Microbiology · 36d
Cleared Sep 20, 1978
MS-2 AUTOMATED URINE SCREENING SYSTEM
K781370
Abbott Laboratories
Microbiology · 43d
Cleared Sep 14, 1978
VAC-U-PAC KIDNEY CASSETTE
K781536
E-Z-Em, Inc.
Radiology · 8d
Cleared Jun 06, 1978
TILL-U-TEST, DIP SLIDE
K780803
Biotron , Ltd.
Microbiology · 26d
Cleared Mar 17, 1978
URINE SCREENING KITS
K780021
Diagnostic Culture System
Microbiology · 72d
Cleared Jan 31, 1978
TILL-U=TEST
K780109
Clinifax Industries, Ltd.
Microbiology · 12d
Cleared Dec 09, 1977
MICROCULT-ID
K771672
Miles Laboratories, Inc.
Microbiology · 99d