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
1537–1560 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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
Cleared Sep 19, 2006
MICROSCAN MICROSTREP PLUS PANEL AZITHROMYCIN
K062585 · LRG
Dade Behring, Inc.
Microbiology · 18d
Cleared Sep 19, 2006
MICROSTREP PLUS PANEL AMOXICILLIN/CLAVULANIC ACID
K062596 · LRG
Dade Behring, Inc.
Microbiology · 18d
Cleared Sep 15, 2006
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND...
K060770 · LOL
Ortho-Clinical Diagnostics, Inc.
Microbiology · 177d
Cleared Sep 14, 2006
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLS
K060678 · LOL
Ortho-Clinical Diagnostics, Inc.
Microbiology · 184d