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
1057–1080 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Not Cleared Aug 21, 2013
VITEK MS
DEN130013 · PEX
bioMerieux, Inc.
Microbiology · 231d
Cleared Aug 14, 2013
PRO HMPV+ ASSAY
K132200 · OEM
Gen-Probe Prodesse, Inc.
Microbiology · 29d
Cleared Aug 14, 2013
PROADENO+ ASSAY
K132159 · OCC
Gen-Probe Prodesse, Inc.
Microbiology · 33d
Cleared Aug 13, 2013
SOFIA(R) RSV FIA
K130398 · GQG
Quidel Corp.
Microbiology · 175d
Cleared Aug 09, 2013
PRODESSE PROFLU+ ASSAY
K132129 · OCC
Gen-Probe Prodesse, Inc.
Microbiology · 30d
Cleared Aug 09, 2013
LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II
K131441 · LGD
DiaSorin, Inc.
Microbiology · 81d
Cleared Aug 07, 2013
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
K132259 · PSZ
Becton, Dickinson and Company
Microbiology · 19d
Cleared Aug 07, 2013
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
K132256 · PSZ
Becton, Dickinson and Company
Microbiology · 19d
Cleared Aug 05, 2013
JBAIDS ANTHRAX DETECTION KIT
K131930 · NHT
Biofire Diagnostics, Inc.
Microbiology · 39d
Cleared Jul 31, 2013
JBAIDS TULAREMIA DETECTION KIT
K131936 · OEH
Biofire Diagnostics, Inc.
Microbiology · 34d
Cleared Jul 31, 2013
JBAIDS PLAGUE DETECTION KIT
K131729 · OIH
Biofire Diagnostics, Inc.
Microbiology · 49d
Not Cleared Jul 25, 2013
XPERT MTB/RIF ASSAY
DEN130032 · PEU
Cepheid
Microbiology · 44d
Cleared Jul 21, 2013
GRAM-NEGATIVE QUICKFISH BC
K123418 · JSS
Advandx, Inc.
Microbiology · 257d
Cleared Jul 17, 2013
IMDX VANR FOR ABBOTT M2000
K123753 · NIJ
Intelligent Medical Devices, Inc.
Microbiology · 223d
Cleared Jul 12, 2013
REMEL XPECT FLU A&B
K131804 · GNX
Remel, Inc.
Microbiology · 23d
Cleared Jul 10, 2013
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML)
K131331 · LON
Becton, Dickinson & CO
Microbiology · 62d
Cleared Jul 05, 2013
SOFIA INFLUENZA A+B FIA
K131606 · GNX
Quidel Corp.
Microbiology · 32d
Cleared Jul 05, 2013
QUICK VUE INFLUENZA
K131599 · GNX
Quidel Corporation
Microbiology · 32d
Cleared Jun 28, 2013
QUICKVUE INFLUENZA A+B
K131619 · GNX
Quidel Corp.
Microbiology · 25d
Cleared Jun 27, 2013
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- IMIPENEM (0.0625-32 UG/ML)
K123404 · LON
Becton, Dickinson & CO
Microbiology · 234d
Cleared Jun 26, 2013
BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN
K123266 · LON
Becton, Dickinson and Company
Microbiology · 250d
Cleared Jun 21, 2013
FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL
K130914 · PEN
Biofire Diagnostics, Inc.
Microbiology · 80d
Cleared Jun 20, 2013
XPERT MRSA/SA BLOOD CULTURE ASSAY
K130894 · NQX
Cepheid
Microbiology · 80d
Cleared Jun 17, 2013
SOFIA STREP A FIA
K123793 · GTY
Quidel Corporation
Microbiology · 189d