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
2113–2136 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Feb 29, 2000
HARDYDISK TOBRAMYCIN, 10MCG
K000182 · JTN
Hardy Diagnostics
Microbiology · 40d
Cleared Feb 29, 2000
HARDYDISK, STREPTOMYCIN 10MCG
K000201 · JTN
Hardy Diagnostics
Microbiology · 39d
Cleared Feb 29, 2000
HYBRID CAPTURE II CT/GC TEST
K981567 · LSL
Digene Corp.
Microbiology · 669d
Cleared Feb 28, 2000
HARDYDISK, PIPERACILLIN, 100MCG
K000183 · JTN
Hardy Diagnostics
Microbiology · 39d
Cleared Feb 28, 2000
DRYSPOT E.COLI 0157 KIT
K993401 · GNA
Oxoid , Ltd.
Microbiology · 143d
Cleared Feb 24, 2000
MERETEK UBT_LITE BREATH TEST FOR H. PYLORI
K000316 · MSQ
Meretek
Microbiology · 23d
Cleared Feb 23, 2000
SYNTHETIC VDRL ANTIGEN
K993633 · GMQ
Centers For Disease Control and...
Microbiology · 119d
Cleared Feb 18, 2000
HARDYDISK, CEFAZOLIN, 30MCG
K000128 · JTN
Hardy Diagnostics
Microbiology · 31d
Cleared Feb 18, 2000
MICROSTREP PLUS PANEL, LEVOFLOXACIN
K983943 · JWY
Dade Microscan, Inc.
Microbiology · 470d
Cleared Feb 17, 2000
HARDYDISK CEFAMANDOLE, 30MCG
K000022 · JTN
Hardy Diagnostics
Microbiology · 44d
Cleared Feb 17, 2000
HARDYDISK OXACILLIN, 1MCG
K994134 · JTN
Hardy Diagnostics
Microbiology · 72d
Cleared Feb 16, 2000
HARDYDISK ERYTHROMYCIN, 15MCG
K994135 · JTN
Hardy Diagnostics
Microbiology · 71d
Cleared Feb 16, 2000
HARDYDISK NORFLOXACIN, 10MCG
K994150 · JTN
Hardy Diagnostics
Microbiology · 70d
Cleared Feb 15, 2000
HARDYDISK MEZLOCILLIN 75MCG
K994212 · JTN
Hardy Diagnostics
Microbiology · 63d
Cleared Feb 11, 2000
HARDYDISK CHLORAMPHENICOL, 30MCG
K994089 · JTN
Hardy Diagnostics
Microbiology · 70d
Cleared Feb 11, 2000
HARDYDISK GENTAMICIN, 10MCG
K994091 · JTN
Hardy Diagnostics
Microbiology · 70d
Cleared Feb 11, 2000
HARDYDISK CEFIXIME, 5MCG
K994129 · JTN
Hardy Diagnostics
Microbiology · 66d
Cleared Feb 10, 2000
COPALIS RUBELLA IGM
K993291 · LFX
DiaSorin, Inc.
Microbiology · 132d
Cleared Feb 10, 2000
YEASTEST
K993554 · JXB
Diagnostic Markers, Inc.
Microbiology · 113d
Cleared Feb 10, 2000
BACT/ALERT SV
K994343 · MDB
Organon Teknika Corp.
Microbiology · 49d
Cleared Feb 09, 2000
HSV-1 ELISA IGG, MODEL EL0910G
K993754 · MXJ
Mrl Diagnostics
Microbiology · 96d
Cleared Feb 01, 2000
HSV-2 ELISA IGG, MODEL EL0920G
K993724 · MYF
Mrl Diagnostics
Microbiology · 90d
Cleared Feb 01, 2000
HARDYDISK CEFACLOR 30MCG
K994046 · JTN
Hardy Diagnostics
Microbiology · 64d
Cleared Jan 27, 2000
QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT
K994004 · LSR
Inova Diagnostics, Inc.
Microbiology · 64d