Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Microbiology ×
7,095 results
1537–1560 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jan 19, 2007
VITEK 2 GRAM POSITIVE AMOXICILLIN FOR STREPTOCOCCUS PNEUMONIAE
K063597 · LON
bioMerieux, Inc.
Microbiology · 46d
Cleared Jan 11, 2007
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTAZIDIME (GN) 0.5-64 UG/ML
K063573 · LON
Becton, Dickinson & CO
Microbiology · 43d
Cleared Jan 11, 2007
VITEK 2 GRAM POSITIVE MEROPENEM FOR STREPTOCOCCUS PNEUMONIAE
K063623 · LON
bioMerieux, Inc.
Microbiology · 36d
Cleared Dec 26, 2006
VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS
K063143 · LFX
Ortho-Clinical Diagnostics, Inc.
Microbiology · 71d
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