JXA · Class I · 21 CFR 866.2660

FDA Product Code JXA: Kit, Screening, Urine

Leading manufacturers include Marion Laboratories, Inc., Miles Laboratories, Inc. and Abbott Laboratories.

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 Feb 03, 1993
BAC-T-SCREEN
K924218
Biomerieux Vitek, Inc.
Microbiology · 167d
Cleared Sep 15, 1989
GEN-PROBE PACE SYSTEM URINE SCREEN
K892216
Gen-Probe, Inc.
Microbiology · 165d
Cleared Jun 10, 1986
SLIDE CULTURE U 'EIKEN'
K861631
Syn-Kit, Inc.
Microbiology · 42d
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 Mar 12, 1984
ORTHO BACTERIURIA DETECTION SYS
K833834
Ortho Diagnostic Systems, Inc.
Immunology · 130d
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 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 Dec 09, 1977
MICROCULT-ID
K771672
Miles Laboratories, Inc.
Microbiology · 99d

About Product Code JXA - Regulatory Context