FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Microbiology ×
7,067 results
1105–1128 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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
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