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
1105–1128 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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
XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI)...
K121539 · NJR
Cepheid
Microbiology · 162d
Cleared Nov 02, 2012
BIOPLEX 2200 EBV IGM KIT
K123021 · LJN
Bio-Rad Laboratories
Microbiology · 36d
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 QUIK CHEK
K121364 · GMZ
Techlab Inc., Corporate Research Center
Microbiology · 148d
Cleared Oct 02, 2012
SHIGA TOXIN CHEK
K121411 · GMZ
Techlab Inc., Corporate Research Center
Microbiology · 144d
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
Cleared Aug 28, 2012
VITEK 2 STRPTOCOCCUS CEFTRIAXONE
K122359 · LON
bioMerieux, Inc.
Microbiology · 25d
Cleared Aug 24, 2012
ELECSYS HSV-2 IGG IMMUNOASSAY
K121895 · JJX
Roche Diagnostics
Microbiology · 56d
Cleared Aug 16, 2012
STRATIFY JCV DXSELECT
K120986 · OYP
Focus Diagnostics, Inc.
Microbiology · 136d
Cleared Aug 16, 2012
VITEK 2 AST-ST CEFOTAXIME
K121863 · LON
bioMerieux, Inc.
Microbiology · 51d
Cleared Aug 07, 2012
VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE
K113783 · LON
bioMerieux, Inc.
Microbiology · 229d
Cleared Aug 07, 2012
BD BACTEC Plus PRIME Aerobic/F Culture Vials
K120994 · MDB
Becton, Dickinson and Company
Microbiology · 127d