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
1057–1080 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Dec 02, 2013
COBAS CT/NG V2.0 TEST
K132270 · LSL
Roche Molecular Systems, Inc.
Microbiology · 133d
Cleared Nov 29, 2013
ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM
K132726 · OZN
Primeradx
Microbiology · 91d
Cleared Nov 26, 2013
BD MAX STAPHSR ASSAY, INSTRUMENT
K132822 · NQX
Geneohm Sciences Canada, Inc. (Bd...
Microbiology · 78d
Cleared Nov 21, 2013
MALDI BIOTYPER CA (MBT-CA) SYSTEM
K130831 · PEX
Bruker Daltonics, Inc.
Microbiology · 240d
Cleared Nov 15, 2013
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV
K133140 · GQG
Becton, Dickinson & CO
Microbiology · 29d
Cleared Nov 15, 2013
VITEK 2 AST ST MEROPENEM
K132507 · LON
bioMerieux, Inc.
Microbiology · 95d
Cleared Nov 13, 2013
BD Veritor™ System Flu A+B Assay
K133138 · PSZ
Becton, Dickinson & CO
Microbiology · 27d
Cleared Nov 08, 2013
MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS
K131275 · LTT
Siemens Helathcare Diagnostics, Inc.
Microbiology · 189d
Cleared Nov 07, 2013
BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV
K132456 · GQG
Becton, Dickinson and Company
Microbiology · 93d
Cleared Oct 21, 2013
PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM
K131630 · LIO
Puritan Medical Products, LLC
Microbiology · 139d
Cleared Oct 17, 2013
MRSA/SA ELITE MGB, ELITE MGB SOFTWARE
K132468 · NQX
Elitechgroup Epoch Biosciences
Microbiology · 71d
Cleared CT Oct 17, 2013
APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)
K132251 · LSL
Hologic / Gen-Probe Incorporated
Microbiology · 90d
Cleared Oct 11, 2013
IMDX C.DIFFICILE FOR ABBOTT M2000
K132235 · OZN
Intelligent Medical Devices, Inc.
Microbiology · 85d
Cleared Oct 10, 2013
VITEK 2 AST-ST TIGECYCLINE
K131779 · LON
bioMerieux, Inc.
Microbiology · 115d
Cleared Oct 09, 2013
VIDAS C DIFFICILE GDH
K132010 · MCB
Biomerieux S.A.
Microbiology · 100d
Cleared Oct 02, 2013
BD Veritor™ System Flu A+B Assay
K132693 · PSZ
Becton, Dickinson and Company
Microbiology · 34d
Cleared Sep 23, 2013
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
K132692 · PSZ
Becton, Dickinson and Company
Microbiology · 25d
Cleared Sep 23, 2013
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
K132508 · OZE
Centers For Disease Control and...
Microbiology · 42d
Cleared Sep 13, 2013
VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN
K132573 · LON
bioMerieux, Inc.
Microbiology · 28d
Cleared Sep 09, 2013
BIOSIGN FLU A + B, STATUS FLU A & B
K132465 · PSZ
Princeton BioMeditech Corp.
Microbiology · 33d
Cleared Sep 06, 2013
QUIDEL MOLECULAR RSV + HMPV ASSAY
K131813 · OCC
Quidel Corp.
Microbiology · 78d
Cleared Aug 29, 2013
QUIDEL MOLECULAR INFLUENZA A + B ASSAY
K131728 · OZE
Quidel Corp.
Microbiology · 78d
Cleared Aug 28, 2013
LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II
K132234 · LGD
DiaSorin, Inc.
Microbiology · 41d
Cleared Aug 26, 2013
PROPARAFLU+ ASSAY
K132238 · OOU
Gen-Probe Prodesse, Inc.
Microbiology · 39d