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
1753–1776 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Feb 03, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN 0.0625-8 UG/ML
K033784 · LON
Becton, Dickinson & CO
Microbiology · 61d
Cleared Feb 03, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT...
K033889 · LON
Becton, Dickinson & CO
Microbiology · 49d
Cleared Jan 23, 2004
DUOPATH VEROTOXINS GLISA TEST
K031367 · GNA
Emd Chemicals, Inc.
Microbiology · 268d
Cleared Jan 21, 2004
IDEIA PCE CHLAMYDIA
K033865 · LJC
Dakocytomation, Ltd.
Microbiology · 40d
Cleared Jan 16, 2004
MODIFICATION TO SERAQUEST EB VCA IGG
K033915 · LSE
Quest Intl., Inc.
Microbiology · 29d
Cleared Jan 15, 2004
MODIFICATION TO SERAQUEST VCA IGM
K033780 · LJN
Quest Intl., Inc.
Microbiology · 42d
Cleared Jan 14, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN/CLAVULANATE-GRAM NEGATIVE
K033557 · LON
Becton, Dickinson & CO
Microbiology · 63d
Cleared Jan 14, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME 0.5-64...
K033560 · LON
Becton, Dickinson & CO
Microbiology · 63d
Cleared Dec 31, 2003
GEN-PROBE APTIMA COMBO 2 ASSAY
K032554 · LSL
Gen-Probe, Inc.
Microbiology · 134d
Cleared Dec 24, 2003
TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS
K032194 · LSL
Gen-Probe, Inc.
Microbiology · 159d
Cleared Dec 19, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM 0.5-64...
K033558 · LON
Becton, Dickinson & CO
Microbiology · 37d
Cleared Dec 09, 2003
REDLINE ANTHRAX ALERT TEST
K030370 · NPO
Tetracore, Inc.
Microbiology · 308d
Cleared Dec 05, 2003
IMMUNOCARDSTAT HPSA
K032222 · LYR
Meridian Bioscience, Inc.
Microbiology · 137d
Cleared Nov 26, 2003
LEGIONELLA PNEUMOPHILA IGG/IGM
K033051 · MJH
Trinity Biotech USA
Microbiology · 58d
Cleared Nov 26, 2003
HERPES GROUP IGG
K033059 · LGC
Trinity Biotech, Inc.
Microbiology · 58d
Cleared Nov 26, 2003
MYCOPLASMA IGG
K033064 · LON
Trinity Biotech USA
Microbiology · 58d
Cleared Nov 26, 2003
PYLORI IGG
K033067 · LYR
Trinity Biotech USA
Microbiology · 58d
Cleared Nov 26, 2003
BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM
K033070 · LSR
Trinity Biotech USA
Microbiology · 58d
Cleared Nov 26, 2003
CHLAMYDIA IGG ELISA TEST SYSTEM
K033079 · LJC
Trinity Biotech USA
Microbiology · 58d
Cleared Nov 26, 2003
BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
K033083 · LSR
Trinity Biotech USA
Microbiology · 58d
Cleared Nov 26, 2003
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN...
K033482 · LON
Dade Behring, Inc.
Microbiology · 22d
Cleared Nov 24, 2003
BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG
K032713 · LSR
Boston Biomedica, Inc.
Microbiology · 83d
Cleared Nov 18, 2003
XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020
K031942 · MHI
Remel, Inc.
Microbiology · 147d
Cleared Nov 18, 2003
PASCO MIC AND MIC/ID PANELS
K033119 · JWY
Pasco Laboratories, Inc.
Microbiology · 49d