FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Microbiology ×
7,061 results
1009–1032 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Feb 28, 2014
HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST
K131334 · MXJ
Gold Standard Diagnostics
Microbiology · 295d
Cleared Feb 27, 2014
SENSITITRE 18-24 HOUR MIC SUCEPTIBILITY SYSTEM
K133773 · JWY
Thermo Fisher Scientific
Microbiology · 77d
Cleared Feb 14, 2014
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE (0.25-16 UG/ML)
K132909 · LON
Becton, Dickinson and Company
Microbiology · 150d
Cleared Jan 31, 2014
WONDFO RAPID STREP A TEST
K133343 · GTY
Guangzhou Wondfo Biotech Co., Ltd.
Microbiology · 93d
Cleared Jan 31, 2014
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
K133038 · NGZ
Trek Diagnostic Systems
Microbiology · 127d
Cleared Jan 17, 2014
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/B...
K133869 · OZE
Center For Disease Control and...
Microbiology · 28d
Cleared Jan 08, 2014
VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)
K132843 · PEN
Nanosphere, Inc.
Microbiology · 120d
Cleared Jan 03, 2014
TRU FLU
K133714 · PSZ
Meridian Bioscience, Inc.
Microbiology · 29d
Cleared Dec 27, 2013
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MEROPENEM (0.125-32 UG/ML)
K132674 · LON
Becton, Dickinson and Company
Microbiology · 122d
Cleared Dec 20, 2013
BD MAX MRSA XT, BD MAX INSTRUMENT
K133605 · NQX
Geneohm Sciences Canada, Inc.
Microbiology · 25d
Cleared Dec 20, 2013
AMPLIVUE GBS ASSAY
K133503 · NJR
Quidel Corporation
Microbiology · 36d
Cleared Dec 18, 2013
ALERE INFLUENZA A & B TEST
K133637 · PSZ
Alere Scarborough, Inc D/B/A Binax, Inc.
Microbiology · 41d
Cleared Dec 10, 2013
BIOSIGN FLU A + B, STATUS FLU A & B
K133474 · PSZ
Princeton BioMeditech Corp.
Microbiology · 28d
Cleared Dec 05, 2013
ALERE BINAXNOW INFLUENZA A & B CARD
K133411 · GNX
Alere Scarborough, Inc D/B/A Binax, Inc.
Microbiology · 28d
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