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
1273–1296 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jan 21, 2011
MAGO 4S
K093101 · LFX
Diamedix Corp.
Microbiology · 477d
Cleared Jan 21, 2011
LIAISON XL ANALYZER MODEL 10050
K103529 · LOL
DiaSorin, Inc.
Microbiology · 51d
Cleared Jan 13, 2011
PLATELIA ASPERGILLUS EIA MODEL 62793
K093678 · NOM
Bio-Rad
Microbiology · 412d
Cleared Jan 10, 2011
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+)
K103209 · OCC
Nanosphere, Inc.
Microbiology · 70d
Cleared Jan 06, 2011
CLEARVIEW EXACT II INFLUENZA A & B TEST
K103610 · PSZ
Alere Scarborough, Inc D/B/A Binax, Inc.
Microbiology · 28d
Cleared Dec 21, 2010
OSOM C. DIFFICILE TOXIN A/B TEST
K102242 · LLH
Genzyme Corporation
Microbiology · 134d
Cleared Dec 17, 2010
HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939
K103538 · JTN
Hardy Diagnostics
Microbiology · 15d
Cleared Dec 16, 2010
GNR TRAFFIC LIGHT PNA FISH
K101558 · JSS
Advandx, Inc.
Microbiology · 195d
Cleared Dec 03, 2010
BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE...
K092587 · LFX
Bio-Rad Laboratories
Microbiology · 466d
Cleared Dec 03, 2010
PRODESSE PROADENO
K102952 · OCC
Gen-Probe Prodesse, Inc.
Microbiology · 59d
Cleared Nov 24, 2010
SIMPLEXA FLU A/B & RSV
K102170 · OCC
Focus Diagnostics, Inc.
Microbiology · 114d
Cleared Nov 17, 2010
ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML
K102668 · JWY
BIOMERIEUX
Microbiology · 62d
Cleared Nov 10, 2010
BIOSIGN FLU A+B
K083746 · PSZ
Princeton BioMeditech Corp.
Microbiology · 693d
Cleared Oct 29, 2010
MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS
K100589 · JSO
Bio-Rad
Microbiology · 241d
Cleared Oct 29, 2010
3M INTEGRATED CYCLER (110V) & (220V)
K102314 · OOI
Focus Diagnostics, Inc.
Microbiology · 74d
Cleared Oct 21, 2010
VITEK 2 GRAM POSITIVE DOXCYCLINE
K093076 · LON
bioMerieux, Inc.
Microbiology · 386d
Cleared Oct 08, 2010
REMEL SPECTRA MRSA
K092407 · JSO
Remel, Inc.
Microbiology · 428d
Cleared Oct 05, 2010
ANTI-HAV
K100903 · LOL
Roche Professional Diagnostics
Microbiology · 187d
Cleared Oct 01, 2010
ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM
K093837 · LIP
Zeus Scientific, Inc. (Zeus)
Microbiology · 290d
Cleared Sep 29, 2010
CRIT-LINE ANEMIA MANAGEMENT SOFTWARE
K093834 · MSQ
Hema Metrics, LLC
Microbiology · 289d
Cleared Sep 28, 2010
VITEK 2 YEAST CASPOFUNGIN
K101566 · NGZ
bioMerieux, Inc.
Microbiology · 116d
Cleared Sep 24, 2010
QUICKVUE RSV 10
K101918 · GQG
Quidel Corp.
Microbiology · 77d
Cleared Sep 10, 2010
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES
K101425 · LRG
Siemens Healthcare Diagnostics
Microbiology · 113d
Cleared Aug 25, 2010
ETEST MOXIFLOXACIN 0.002-32 UG/ML
K093604 · JWY
Ab Biomerieux
Microbiology · 278d