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
1153–1176 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Mar 26, 2012
BIOPLEX 2200 TORC IGG
K120572 · OMI
Bio-Rad Laboratories, Inc.
Microbiology · 28d
Cleared Mar 23, 2012
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
K120049 · PSZ
Becton, Dickinson and Company
Microbiology · 77d
Cleared Mar 16, 2012
BD BACTEC Plus Aerobic/F Culture Vials (plastic)
K113558 · MDB
Becton, Dickinson and Company
Microbiology · 106d
Cleared Mar 15, 2012
QUIDEL MOLECULAR INFLUENZA A+B
K113777 · OZE
Quidel Corp.
Microbiology · 85d
Cleared Mar 14, 2012
BIOPLEX 2200 EBV IGG AND SYPHILIS IGG
K120439 · LIP
Bio-Rad Laboratories, Inc.
Microbiology · 30d
Cleared Mar 02, 2012
HELICOBACTER PYLORI ELISA IGG TEST KIT
K110745 · LYR
Gold Standard Diagnostics
Microbiology · 351d
Cleared Mar 01, 2012
TRANSPORT CULTURE MEDIUM DEVICE
K113249 · JSM
Puritan Medical Products, LLC
Microbiology · 119d
Cleared Feb 28, 2012
VITEK(R) 2 STREPTOCOCCUS TETRACYCLINE
K111893 · LON
bioMerieux, Inc.
Microbiology · 238d
Cleared Feb 24, 2012
TRU LEGIONELLA
K113190 · MJH
Meridian Bioscience, Inc.
Microbiology · 116d
Cleared Feb 17, 2012
VITEK 2 STREPTOCOCCUS ERYTHROMYCIN
K111976 · LON
bioMerieux, Inc.
Microbiology · 220d
Cleared Feb 17, 2012
TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I)
K112781 · OCC
Luminex Molecular Diagnostics, Inc.
Microbiology · 144d
Cleared Feb 16, 2012
BD MAX GBS ASSAY, BD MAX INSTRUMENT
K111860 · NJR
Becton, Dickinson & CO
Microbiology · 231d
Cleared Feb 10, 2012
VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE
K113305 · LON
bioMerieux, Inc.
Microbiology · 93d
Cleared Feb 06, 2012
ROTOR-GENE Q MDX
K113319 · OOI
QIAGEN GmbH
Microbiology · 88d
Cleared Feb 06, 2012
ARTUS INFL A/B RG RT-PCR KIT
K113323 · OCC
QIAGEN GmbH
Microbiology · 88d
Cleared Feb 01, 2012
GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT
K110899 · LYR
Gold Standard Diagnostics
Microbiology · 308d
Cleared Jan 24, 2012
COBAS 4800 CT / NG TEST
K110923 · MKZ
Roche Molecular Systems, Inc.
Microbiology · 298d
Cleared Jan 20, 2012
TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS
K112343 · LIP
Siemens Healthcare Diagnostics, Inc.
Microbiology · 158d
Not Cleared Jan 20, 2012
STRATIFY JCV(TM) ANTIBODY
DEN120008 · OYP
Focus Diagnostics, Inc.
Microbiology · 14d
Cleared Dec 22, 2011
QUIDEL MOLECULAR INFLUENZA A + B ASSAY
K112172 · OCC
Quidel Corp.
Microbiology · 147d
Cleared Dec 16, 2011
IMMUNOCARD C. DIFFICILE GDH
K112048 · MCB
Meridian Bioscience, Inc.
Microbiology · 151d
Cleared Dec 16, 2011
VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)
K112424 · NQX
Nanosphere, Inc.
Microbiology · 115d
Cleared Dec 15, 2011
QUIDEL MOLECULAR HMPV ASSAY
K112490 · OEM
Quidel Corp.
Microbiology · 108d
Cleared Dec 05, 2011
ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT
K112125 · NJR
Meridian Bioscience, Inc.
Microbiology · 133d