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
1561–1584 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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
Cleared Oct 27, 2006
MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML)
K063065 · LRG
Dade Behring, Inc.
Microbiology · 21d
Cleared Oct 26, 2006
MICROSCAN MICROSTREP PLUS PANEL ERYTHROMYCIN (0.015 TO 2 MCG/ML)
K062375 · LRG
Dade Behring, Inc.
Microbiology · 72d
Cleared Oct 26, 2006
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062783 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 38d
Cleared Oct 26, 2006
MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML)
K063053 · LRG
Dade Behring, Inc.
Microbiology · 22d
Cleared Oct 26, 2006
MICROSCAN MICROSTREP PLUS PANEL CEFTRIAXONE (0.015-8MCG/ML)
K063064 · LRG
Dade Behring, Inc.
Microbiology · 20d
Cleared Oct 25, 2006
C. ALBICANS PNA FISH
K062461 · JXB
Advandx, Inc.
Microbiology · 63d
Cleared Oct 24, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEN - TICARCILLIN-CLAVULANATE (GN) 1/2 -...
K062687 · LON
Becton, Dickinson & CO
Microbiology · 46d
Cleared Oct 20, 2006
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH LINEZOLID
K062705 · LON
Dade Behring, Inc.
Microbiology · 39d
Cleared Oct 20, 2006
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062722 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 38d
Cleared Oct 18, 2006
LIAISON EA IGG
K060204 · LSE
DiaSorin, Inc.
Microbiology · 265d
Cleared Oct 18, 2006
MASTALEX -MRSA, MODEL RST501
K062864 · MYI
Mast Group , Ltd.
Microbiology · 23d
Cleared Oct 13, 2006
APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM
K061413 · MKZ
Gen-Probe, Inc.
Microbiology · 144d
Cleared Oct 13, 2006
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062681 · JWY
Trek Diagnostic Systems, Ltd.
Microbiology · 35d
Cleared Oct 13, 2006
MICROSCAN MICROSTREP PLUS PANEL, PENICILLIN
K062773 · LTT
Dade Behring, Inc.
Microbiology · 25d
Cleared Oct 13, 2006
MICROSCAN MICROSTREP PLUS PANEL TETRACYCLINE (0.006 TO 16 MCG/ML)
K062923 · LRG
Dade Behring, Inc.
Microbiology · 15d
Cleared Oct 12, 2006
MICROSCAN MICROSTREP PLUS PANEL AMPICILLIN (0.013 - 16 MCG/ML)
K062927 · LRG
Dade Behring, Inc.
Microbiology · 14d
Cleared Oct 10, 2006
MICROSCAN MICROSTREP PLUS PANEL, CLINDAMYCIN
K062777 · LTT
Dade Behring, Inc.
Microbiology · 22d
Cleared Oct 05, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN (GN) 1-128 UG/ML
K062680 · LON
Becton, Dickinson & CO
Microbiology · 27d
Cleared Oct 04, 2006
TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196
K061509 · LSL
Gen-Probe, Inc.
Microbiology · 125d
Cleared Sep 19, 2006
VITEK 2 AST-YS FLUCONAZOLE
K061945 · NGZ
bioMerieux, Inc.
Microbiology · 71d