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
1633–1656 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Mar 23, 2006
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH VANCOMYCIN...
K060312 · LON
Dade Behring, Inc.
Microbiology · 43d
Cleared Mar 17, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN-0.0625-8 UG/ML, AND...
K060218 · LON
Becton, Dickinson & CO
Microbiology · 49d
Cleared Mar 17, 2006
TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K060286 · JTN
Oxoid , Ltd.
Microbiology · 42d
Cleared Mar 10, 2006
PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480
K053335 · LYR
Meridian Bioscience, Inc.
Microbiology · 99d
Cleared Mar 09, 2006
BD PHOENIX AUTOMATED MIRCROBIOLOGY SYSTEM TETRACYCLINE-GN 0.5-16 UG/ML AND GP...
K060214 · LON
Becton, Dickinson & CO
Microbiology · 41d
Cleared Feb 24, 2006
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN...
K053504 · LON
Dade Behring, Inc.
Microbiology · 70d
Cleared Feb 21, 2006
GENZYME OSOM INFLUENZA A & B TEST
K051244 · PSZ
Genzyme Corp.
Microbiology · 281d
Cleared Feb 08, 2006
DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS
K052499 · LGD
Diasorin S.P.A
Microbiology · 148d
Cleared Feb 03, 2006
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - AMPICILLIN
K060088 · LON
Dade Behring, Inc.
Microbiology · 22d
Not Cleared Feb 03, 2006
INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET
DEN060008 · NXD
Centers For Disease Control and...
Microbiology · 7d
Cleared Jan 20, 2006
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K053243 · LRG
Trek Diagnostic Systems, Inc.
Microbiology · 60d
Cleared Jan 19, 2006
VERSATREK MYCO PZA KIT
K052323 · MJA
Trek Diagnostic Systems, Inc.
Microbiology · 147d
Cleared Jan 17, 2006
SHERLOCK MICROBIAL IDENTIFICATION SYSTEM FOR BIODEF
K052485 · NWZ
Midi, Inc.
Microbiology · 130d
Cleared Dec 22, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN GP 1-32 G/ML
K053241 · LON
Becton, Dickinson & CO
Microbiology · 34d
Cleared Dec 14, 2005
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323
K052645 · GTQ
Ortho-Clinical Diagnostics
Microbiology · 79d
Cleared Dec 14, 2005
VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN
K053097 · LON
bioMerieux, Inc.
Microbiology · 41d
Cleared Dec 14, 2005
QUICKVUE INFLUENZA A + B TEST
K053146 · PSZ
Quidel Corp.
Microbiology · 34d
Cleared Dec 06, 2005
INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC
K051638 · GTY
Unipath , Ltd.
Microbiology · 169d
Cleared Dec 05, 2005
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM.
K051484 · LFY
Zeus Scientific, Inc.
Microbiology · 182d
Cleared Dec 01, 2005
VITEK 2 GRAM POSITIVE TELITHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
K053186 · LON
bioMerieux, Inc.
Microbiology · 17d
Cleared Nov 30, 2005
BINAXNOW INFLUENZA A & B TEST
K053126 · PSZ
Binax, Inc.
Microbiology · 23d
Cleared Nov 28, 2005
BD VIPER SYSTEM
K052481 · LSL
Becton, Dickinson & CO
Microbiology · 80d
Cleared Nov 22, 2005
RPS ADENO DETECTOR
K052092 · GOD
Rapid Pathogen Screening
Microbiology · 112d
Cleared Nov 18, 2005
JBAIDS ANTHRAC DETECTION SYSTEM
K051713 · NHT
Idaho Technology, Inc.
Microbiology · 144d