FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Microbiology ×
7,067 results
1873–1896 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Nov 12, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K023301 · LON
Becton, Dickinson & CO
Microbiology · 40d
Cleared Nov 12, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMIKACIN-0.5-64 UG/ML
K023444 · LON
Becton, Dickinson & CO
Microbiology · 28d
Cleared Oct 31, 2002
SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM
K020689 · NJO
Midi, Inc.
Microbiology · 241d
Cleared Oct 31, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GENTAMICIN 0.25 - 16 UG/ML
K023273 · LON
Becton, Dickinson & CO
Microbiology · 30d
Cleared Oct 25, 2002
NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES...
K022356 · LYR
Nichols Institute Diagnostics
Microbiology · 98d
Cleared Oct 23, 2002
MICROSCAN SYNERGIES PLUS
K023202 · JWY
Dade Microscan, Inc.
Microbiology · 28d
Cleared Oct 17, 2002
SAS STREPALERT
K023270 · GTY
Sa Scientific, Inc.
Microbiology · 16d
Cleared Oct 08, 2002
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K022656 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 60d
Cleared Sep 30, 2002
BIO-RAD PLATELIA TOXO IGM TMB
K013837 · LGD
Bio-Rad
Microbiology · 315d
Cleared Sep 30, 2002
BIO-RAD PLATELIA TOXO IGG TMB
K013839 · LGD
Bio-Rad
Microbiology · 315d
Cleared Sep 27, 2002
EBV EA-D IGG ELISA KIT, MODEL EBG-100
K021793 · LSE
Pan Bio Pty. , Ltd.
Microbiology · 119d
Cleared Sep 25, 2002
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K021997 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 98d
Cleared Sep 25, 2002
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K022775 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 47d
Cleared Sep 19, 2002
BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN...
K021646 · PSZ
Binax, Inc.
Microbiology · 122d
Cleared Sep 19, 2002
BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN...
K021649 · PSZ
Binax, Inc.
Microbiology · 122d
Cleared Sep 17, 2002
IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96
K020583 · MHI
Ivd Research, Inc.
Microbiology · 208d
Cleared Sep 17, 2002
GEN-PROBE APTIMA COMBO 2 ASSAY
K022874 · JTW
Gen-Probe, Inc.
Microbiology · 53d
Cleared Sep 13, 2002
RSV OIA
K021172 · GOG
Thermo Biostar, Inc.
Microbiology · 154d
Cleared Sep 13, 2002
BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN...
K021687 · GQG
Binax, Inc.
Microbiology · 114d
Cleared Aug 22, 2002
XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT
K020226 · JWZ
Hellen Professional Services
Microbiology · 212d
Cleared Aug 15, 2002
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID
K022045 · LON
bioMerieux, Inc.
Microbiology · 52d
Cleared Aug 12, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K022172 · LON
Becton, Dickinson & CO
Microbiology · 40d
Cleared Aug 01, 2002
HERPESELECT 2 ELISA IGG, MODEL ELO920G
K021486 · MXJ
Focus Technologies, Inc.
Microbiology · 90d
Cleared Aug 01, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CLINDAMYCIN 0.125-8.0MCG/ML
K021954 · LON
Becton, Dickinson & CO
Microbiology · 48d