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
1297–1320 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Aug 20, 2010
BBL CHROMAGAR MRSA II
K092767 · JSO
Becton, Dickinson & CO
Microbiology · 345d
Cleared Jul 28, 2010
XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10
K101879 · NQX
Cepheid
Microbiology · 22d
Cleared Jul 23, 2010
PROFAST+ ASSAY
K101855 · OQW
Gen-Probe Prodesse, Inc.
Microbiology · 22d
Cleared Jul 22, 2010
AUDIT MICROCV PROCALCITONIN LINEARITY
K101434 · MJX
Aalto Scientific, Ltd.
Microbiology · 62d
Cleared Jul 16, 2010
ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM
K093784 · OPM
Zeus Scientific, Inc.
Microbiology · 219d
Cleared Jul 15, 2010
REMEL SPECTRA VRE
K092819 · JSO
Thermo Fisher Scientific
Microbiology · 304d
Cleared Jul 15, 2010
YEAST TRAFFIC LIGHT PNA FISH
K093024 · NZS
Advandx, Inc.
Microbiology · 289d
Cleared Jul 09, 2010
ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL...
K100818 · OMN
Meridian Bioscience, Inc.
Microbiology · 108d
Cleared Jul 09, 2010
BD DIRECTIGEN EZ RSV
K101514 · GQG
Becton, Dickinson & CO
Microbiology · 37d
Cleared Jul 06, 2010
LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT,...
K091409 · NQX
Roche Molecular Systems, Inc.
Microbiology · 419d
Cleared Jul 06, 2010
NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS...
K093383 · OOI
bioMerieux, Inc.
Microbiology · 249d
Cleared Jul 06, 2010
JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136
K100287 · NXD
U.S. Army Medical Material...
Microbiology · 158d
Cleared Jul 06, 2010
ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM
K100728 · LSR
Zeus Scientific, Inc.
Microbiology · 113d
Cleared Jun 24, 2010
BD DIRECTIGEN EX FLU A+B
K101461 · PSZ
Becton, Dickinson and Company
Microbiology · 29d
Cleared Jun 22, 2010
ANTI-HAV IGM
K093955 · LOL
Roche Diagnostics
Microbiology · 181d
Cleared Jun 22, 2010
CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL
K101564 · OQW
Centers For Disease Control and...
Microbiology · 18d
Cleared Jun 14, 2010
BD DIRECTIGEN EZ FLU A+B ASSAY
K101529 · PSZ
Becton, Dickinson & CO
Microbiology · 12d
Cleared Jun 01, 2010
XPERT MRSA/SA NASAL ASSAY
K100822 · NQX
Cepheid
Microbiology · 70d
Cleared May 28, 2010
ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT,...
K092704 · LSK
Abbott Molecular, Inc.
Microbiology · 267d
Cleared May 28, 2010
ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02...
K092705 · OOI
Abbott Molecular, Inc.
Microbiology · 267d
Cleared May 27, 2010
HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION...
K090191 · NJR
Handylab, Inc.
Microbiology · 485d
Cleared May 24, 2010
SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500
K100148 · OQW
Focus Diagnostics, Inc.
Microbiology · 125d
Cleared May 21, 2010
VITEK 2 YEAST VORICONAZOLE
K092454 · NGZ
bioMerieux, Inc.
Microbiology · 284d
Cleared May 21, 2010
AUDIT MICROCV ASO LINEARITY SET, MODEL K721M-5
K100750 · JJX
Aalto Scientific, Ltd.
Microbiology · 66d