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
1777–1800 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Feb 25, 2004
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/CLAVULANATE...
K033940 · LTT
Dade Behring, Inc.
Microbiology · 68d
Cleared Feb 11, 2004
WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254
K023889 · MIU
Wiener Laboratories Saic
Microbiology · 447d
Cleared Feb 10, 2004
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML
K032706 · JWY
Dade Behring, Inc.
Microbiology · 161d
Cleared Feb 03, 2004
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K033522 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 88d
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