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
1513–1536 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Dec 22, 2006
ENTEROCOCCUS FAECALIS PNA FISH
K063127 · OAH
Advandx, Inc.
Microbiology · 70d
Cleared Dec 21, 2006
VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
K063492 · LON
bioMerieux, Inc.
Microbiology · 34d
Cleared Dec 20, 2006
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC AND SUSCEPTIBILITY...
K062841 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 89d
Cleared Dec 12, 2006
BIOSTAR OIA SHIGATOX
K061889 · GMZ
Inverness Medical-Biostar, Inc.
Microbiology · 162d
Cleared Dec 08, 2006
BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
K062211 · LSE
Bio-Rad Laboratories, Inc.
Microbiology · 129d
Cleared Dec 08, 2006
BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
K062213 · LSE
Bio-Rad Laboratories, Inc.
Microbiology · 129d
Cleared Dec 08, 2006
SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
K062948 · NJR
Cepheid
Microbiology · 71d
Cleared Dec 08, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) 0.5-64UG/ML
K063301 · LON
Becton, Dickinson & CO
Microbiology · 37d
Cleared Dec 08, 2006
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH GENTAMICIN (0.06-32MG/ML...
K063365 · LON
Dade Behring, Inc.
Microbiology · 31d
Cleared Dec 08, 2006
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANEL WITH SYNERCID...
K063366 · LON
Dade Behring, Inc.
Microbiology · 31d
Cleared Nov 30, 2006
SPECTRAL WEST NILE VIRUS IGM STATUS TEST
K052519 · NOP
Spectral Diagnostics, Inc.
Microbiology · 442d
Cleared Nov 27, 2006
MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN
K063299 · LRG
Dade Behring, Inc.
Microbiology · 26d
Cleared Nov 21, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERTAPENEM (GN) 0.25-32 UG/ML
K062945 · LON
Becton, Dickinson & CO
Microbiology · 54d
Cleared Nov 20, 2006
D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
K061101 · GNW
Diagnostic Hybrids, Inc.
Microbiology · 214d
Cleared Nov 20, 2006
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH NITROFURANTOIN...
K062938 · LON
Dade Behring, Inc.
Microbiology · 53d
Cleared Nov 16, 2006
RAPIRUN H. PYLORI ANTIBODY DETECTION KIT
K052716 · LYR
Otsuka Pharmaceutical Co., Ltd.
Microbiology · 413d
Cleared Nov 15, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (GN) 0.5-64UG/ML
K062944 · LON
Becton, Dickinson & CO
Microbiology · 48d
Cleared Nov 09, 2006
BINAXNOW INFLUENZA A & B TEST
K062109 · PSZ
Binax, Inc.
Microbiology · 108d
Cleared Nov 09, 2006
MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062839 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 49d
Cleared Nov 09, 2006
MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML)
K063102 · LRG
Dade Behring, Inc.
Microbiology · 30d
Cleared Nov 07, 2006
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091
K062440 · LSL
Gen-Probe, Inc.
Microbiology · 78d
Cleared Nov 01, 2006
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062816 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 42d
Cleared Nov 01, 2006
MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML)
K063099 · LRG
Dade Behring, Inc.
Microbiology · 22d
Cleared Nov 01, 2006
MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML
K063101 · LRG
Dade Behring, Inc.
Microbiology · 22d