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
1153–1176 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Sep 13, 2012
STREPTOCOCCUS APP. SEROLOGICAL REAGENTS
K122019 · OYZ
Meridian Bioscience, Inc.
Microbiology · 65d
Cleared Sep 10, 2012
ESENSOR RESPIRATORY VIRAL PANEL
K113731 · JJH
Clinical Micro Sensors, Inc.
Microbiology · 266d
Cleared Sep 07, 2012
BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B
K121797 · PSZ
Becton, Dickinson and Company
Microbiology · 80d
Cleared Sep 06, 2012
LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM
K122397 · LFX
DiaSorin, Inc.
Microbiology · 30d
Cleared Aug 28, 2012
VITEK 2 STRPTOCOCCUS CEFTRIAXONE
K122359 · LON
bioMerieux, Inc.
Microbiology · 25d
Cleared Aug 24, 2012
ELECSYS HSV-2 IGG IMMUNOASSAY
K121895 · JJX
Roche Diagnostics
Microbiology · 56d
Cleared Aug 16, 2012
VITEK 2 AST-ST CEFOTAXIME
K121863 · LON
bioMerieux, Inc.
Microbiology · 51d
Cleared Aug 16, 2012
STRATIFY JCV DXSELECT
K120986 · OYP
Focus Diagnostics, Inc.
Microbiology · 136d
Cleared Aug 07, 2012
BD BACTEC Plus PRIME Aerobic/F Culture Vials
K120994 · MDB
Becton, Dickinson and Company
Microbiology · 127d
Cleared Aug 07, 2012
VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE
K113783 · LON
bioMerieux, Inc.
Microbiology · 229d
Cleared Jul 26, 2012
ALERE PBP2A TEST
K121905 · MYI
Alere Scarborough, Inc.
Microbiology · 27d
Cleared Jul 26, 2012
ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM
K113397 · LSR
Zeus Scientific, Inc.
Microbiology · 252d
Cleared Jul 25, 2012
ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV
K120625 · MXJ
Roche Diagnostics
Microbiology · 146d
Cleared Jul 13, 2012
SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK
K120413 · OCC
Focus Diagnostics, Inc.
Microbiology · 154d
Cleared Jul 05, 2012
BD MAX MRSA ASSAY, BD MAX INSTRUMENT
K120138 · NQX
Bd Diagnostics (Geneohm Sciences...
Microbiology · 170d
Cleared Jun 29, 2012
VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM
K113200 · LON
bioMerieux, Inc.
Microbiology · 242d
Cleared Jun 28, 2012
ARCHITECT HAVAB-G
K113704 · LOL
Abbott Laboratories
Microbiology · 195d
Not Cleared Jun 26, 2012
VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)
DEN120014 · PAM
Nanosphere, Inc.
Microbiology · 11d
Cleared Jun 22, 2012
BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT
K120959 · MXJ
Bio-Rad Laboratories
Microbiology · 84d
Cleared Jun 08, 2012
TRANSPORT CULTURE MEDIUM DEVICE
K120846 · LIO
Puritan Medical Products, LLC
Microbiology · 80d
Cleared Jun 01, 2012
BORRELIA BURGDORFERI IGM BLOT TEST
K113846 · LSR
Gold Standard Diagnostics
Microbiology · 155d
Cleared Jun 01, 2012
MRSA/SA ELITE MGB
K112937 · NQX
Elitech
Microbiology · 242d
Cleared May 25, 2012
COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM
K121039 · JTW
Copan Flock Technologies
Microbiology · 50d
Not Cleared May 24, 2012
CDC DENV-1-4 REAL TIME RT-PCT ASSAY
DEN120012 · OZB
Centers For Disease Control and...
Microbiology · 73d