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
1129–1152 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jan 16, 2013
PRO HMPV+ ASSAY
K123838 · OEM
Gen-Probe Prodesse, Inc.
Microbiology · 34d
Cleared Jan 16, 2013
PROGASTRO SSCS ASSAY
K123274 · PCH
Gen-Probe Prodesse, Inc.
Microbiology · 89d
Cleared Jan 14, 2013
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
K123905 · OQW
Centers For Disease Control and...
Microbiology · 26d
Not Cleared Jan 14, 2013
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR...
DEN130003 · PCH
Luminex Molecular Diagnostics, Inc.
Microbiology · 3d
Cleared Jan 09, 2013
APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER
K122062 · OUY
Gen-Probe, Inc.
Microbiology · 180d
Cleared Jan 07, 2013
ENTEROCOCCUS QUICKFISH BC
K121991 · OAH
Advandx, Inc.
Microbiology · 185d
Cleared Dec 27, 2012
XPERT CT/NG
K121710 · LSL
Cepheid
Microbiology · 199d
Cleared Dec 21, 2012
XPERT FLU
K123191 · OCC
Cepheid
Microbiology · 71d
Cleared Dec 21, 2012
ABBOTT PLEX-ID FLU ASSAY
K121003 · OCC
Abbott Laboratories
Microbiology · 263d
Cleared Dec 17, 2012
ALPHA CRYPTOCOCCAL ANTIGEN EIA
K120946 · MDU
Immuno-Mycologics, Inc.
Microbiology · 263d
Cleared Dec 13, 2012
AMPLIVUE C. DIFFICILE ASSAY
K123355 · OZN
Quidel Corporation
Microbiology · 43d
Cleared Dec 05, 2012
VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)
K123197 · OZN
Nanosphere, Inc.
Microbiology · 55d
Cleared Nov 20, 2012
VITEK 2 GRAM NEGATIVE DOXYCYCLINE
K121546 · LON
bioMerieux, Inc.
Microbiology · 179d
Cleared Nov 19, 2012
VITEK 2 AST STREPTOCOCUS VANCOMYCIN
K121100 · LON
bioMerieux, Inc.
Microbiology · 222d
Cleared Nov 06, 2012
VRESELECT CULTURE MEDIUM
K122187 · JSO
Bio-Rad
Microbiology · 105d
Cleared Nov 05, 2012
OSOM INFLUENZA A&B TEST MODEL 190
K123182 · GNX
SEKISUI Diagnostics, LLC
Microbiology · 26d
Cleared Nov 02, 2012
BIOPLEX 2200 EBV IGM KIT
K123021 · LJN
Bio-Rad Laboratories
Microbiology · 36d
Cleared Nov 02, 2012
XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI)...
K121539 · NJR
Cepheid
Microbiology · 162d
Cleared Oct 15, 2012
GRAM POSTITVE CLINDAMYCIN
K122547 · LON
bioMerieux, Inc.
Microbiology · 55d
Cleared Oct 12, 2012
ETEST CEFTAROLINE
K121002 · JWY
bioMerieux, Inc.
Microbiology · 193d
Cleared Oct 02, 2012
SHIGA TOXIN CHEK
K121411 · GMZ
Techlab Inc., Corporate Research Center
Microbiology · 144d
Cleared Oct 02, 2012
SHIGA TOXIN QUIK CHEK
K121364 · GMZ
Techlab Inc., Corporate Research Center
Microbiology · 148d
Cleared Sep 19, 2012
VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST
K122514 · PAM
Nanosphere, Inc.
Microbiology · 33d
Cleared Sep 18, 2012
BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV
K121633 · GQG
Becton, Dickinson and Company
Microbiology · 106d