Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Microbiology ×
7,095 results
1897–1920 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Dec 13, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MOXIFLOXACIN...
K023541 · LON
Dade Behring, Inc.
Microbiology · 52d
Cleared Dec 10, 2002
BD DIRECTIGEN EZ RSV KIT
K022133 · GQG
Becton, Dickinson & CO
Microbiology · 162d
Cleared Nov 20, 2002
QUICKLAB RSV
K021789 · GQG
Integrated Biotechnology Corp.
Microbiology · 173d
Cleared Nov 18, 2002
IDI-STREP B ASSAY
K022504 · NJR
Infectio Diagnostic, Inc.
Microbiology · 112d
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