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
1633–1656 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Nov 04, 2005
CRYPTOSPORIDIUM II
K052932 · MHJ
Techlab, Inc.
Microbiology · 16d
Cleared Oct 26, 2005
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS
K052346 · LON
Dade Behring, Inc.
Microbiology · 58d
Cleared Oct 13, 2005
ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA,...
K052366 · JWY
Ab Biodisk
Microbiology · 45d
Cleared Oct 05, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (STREP) 0.125 - 4UG/ML
K052270 · LON
Becton, Dickinson & CO
Microbiology · 47d
Cleared Oct 03, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -CIPROFLOXACIN GN
K052269 · LON
Becton, Dickinson & CO
Microbiology · 45d
Cleared Sep 30, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TOBRAMYCIN (GP) 0.5-16UG/ML
K052250 · LON
Becton, Dickinson & CO
Microbiology · 43d
Cleared Sep 29, 2005
VITEK 2 GRAM NEGATIVE TIGECYCLINE
K052311 · LON
bioMerieux, Inc.
Microbiology · 36d
Cleared Sep 21, 2005
SENSITIRE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS
K052091 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 50d
Cleared Sep 12, 2005
BD PROBE TEC URINE PRESERVATIVE TRANSPORT
K052224 · LSL
Becton, Dickinson & CO
Microbiology · 27d
Cleared Aug 16, 2005
GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS
K051794 · NVQ
Office of the Surgeon General, U.S. Army
Microbiology · 46d
Cleared Aug 16, 2005
VITEK 2 GRAM POSITIVE ERTAPENEM FOR STREPTOCOCCUS PNEUMONIAE
K051849 · LON
bioMerieux, Inc.
Microbiology · 40d
Cleared Aug 11, 2005
VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT
K051071 · LSR
Viramed Biotech AG
Microbiology · 107d
Cleared Aug 11, 2005
BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT
K051169 · LSR
Viramed Biotech AG
Microbiology · 104d
Cleared Aug 09, 2005
GEN-PROBE APTIMA COMBO 2 ASSAY
K043224 · LSL
Gen-Probe, Inc.
Microbiology · 260d
Cleared Aug 05, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - DAPTOMYCIN 0.125 - 32 UG/ML
K051689 · LON
Becton, Dickinson & CO
Microbiology · 43d
Cleared Jul 27, 2005
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - RIFAMPIN
K051478 · LON
Dade Behring, Inc.
Microbiology · 54d
Cleared Jul 25, 2005
TOX A/B QUICK CHEK
K050891 · LLH
Techlab, Inc.
Microbiology · 108d
Cleared Jul 25, 2005
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS
K051350 · LON
Dade Behring, Inc.
Microbiology · 62d
Cleared Jul 14, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMOXICILLIN (STREP) 0.0313 - 32 UG/ML
K051692 · LON
Becton, Dickinson & CO
Microbiology · 21d
Cleared Jul 12, 2005
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MINIMUM INHIBITORY CONCENTRATION/COMBO...
K051311 · LON
Dade Behring, Inc.
Microbiology · 54d
Cleared Jul 11, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CLINDAMYCIN (STREP) 0.03125 -4 UG/ML
K051272 · LON
Becton, Dickinson & CO
Microbiology · 55d
Cleared Jul 07, 2005
BD DIRECTIGEN EZ FLU A + B
K042472 · PSZ
Becton, Dickinson & CO
Microbiology · 300d
Cleared Jul 05, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - LINEZOLID (STREP) 0.25 - 16UG/ML
K051266 · LON
Becton, Dickinson & CO
Microbiology · 50d
Cleared Jun 24, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFEPIME (STREP) 0.0625-4UG/ML
K051204 · LON
Becton, Dickinson & CO
Microbiology · 44d