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
1657–1680 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Nov 17, 2005
GIARDIA/CRYPTOSPORIDIUM CHEK
K051929 · MHJ
Techlab, Inc.
Microbiology · 127d
Cleared Nov 17, 2005
TIGECYCLINE 15UG BBL SENSI-DISC
K052853 · JTN
Becton, Dickinson & CO
Microbiology · 37d
Cleared Nov 14, 2005
TELITHROMYCIN 15UG BBL SENSI-DISC
K052876 · JTN
Becton, Dickinson & CO
Microbiology · 33d
Cleared Nov 07, 2005
VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN
K052656 · LON
bioMerieux, Inc.
Microbiology · 42d
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