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
1273–1296 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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
Cleared May 13, 2010
IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM...
K100433 · LKQ
Siemens Healthcare Diagnostics
Microbiology · 86d
Cleared May 12, 2010
MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711
K100336 · OQO
Eragen Biosciences
Microbiology · 96d
Cleared May 10, 2010
CLEARVIEW EXACT II INFLUENZA A & B TEST
K092349 · PSZ
Inverness Medical, Inc.
Microbiology · 279d
Cleared Apr 14, 2010
BINAXNOW PBP2A TEST, MODEL 890-000
K090301 · MYI
Binax, Inc.
Microbiology · 432d
Cleared Mar 29, 2010
BIOPLEX 2200 MMRV IGG
K091616 · OPL
Bio-Rad Laboratories
Microbiology · 299d
Cleared Mar 29, 2010
TELAVANCIN 30 UG, BBL SENSI-DISC
K100722 · JTN
Becton, Dickinson and Company
Microbiology · 14d
Cleared Mar 12, 2010
ELECSYS RUBELLA IGM IMMUNOASSAY
K092322 · LFX
Roche Diagnostics
Microbiology · 220d
Cleared Mar 12, 2010
C. ALBICANS/C. GLABRATA PNA FISH
K092784 · NZS
Advandx, Inc.
Microbiology · 183d
Cleared Mar 12, 2010
LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124
K093815 · OMG
Millipore Corporation
Microbiology · 88d
Cleared Mar 09, 2010
POC-AS10 AUTO SAMPLER
K092817 · MSQ
Otsuka Pharmaceutical Co., Ltd.
Microbiology · 176d