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
5593–5616 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Mar 23, 1984
SDL LISTERIA MONOCYTOGENES CONTROL
K840503 · GSI
Scientific Device Laboratory, Inc.
Microbiology · 46d
Cleared Mar 23, 1984
SDL NEISSERIA MENINGITIDES GR. 2
K840504 · LSC
Scientific Device Laboratory, Inc.
Microbiology · 46d
Cleared Mar 23, 1984
SDL NEISSERIA MENNINGITIDIS GR. X
K840505 · LSC
Scientific Device Laboratory, Inc.
Microbiology · 46d
Cleared Mar 23, 1984
NEISSERIA MENINGITIDIS GR. Y
K840507 · LSC
Scientific Device Laboratory, Inc.
Microbiology · 46d
Cleared Mar 23, 1984
NEISSERIA MENINGITIDIS GR. C
K840508 · JTO
Scientific Device Laboratory, Inc.
Microbiology · 46d
Cleared Mar 23, 1984
NEISSERIA MENINGITIDIS GR. B
K840509 · LSC
Scientific Device Laboratory, Inc.
Microbiology · 46d
Cleared Mar 23, 1984
NEISSERIA MENINGITIDIS GR. A
K840510 · LSC
Scientific Device Laboratory, Inc.
Microbiology · 46d
Cleared Mar 23, 1984
STREPTOCOCCUS GR. D
K840511 · GTY
Scientific Device Laboratory, Inc.
Microbiology · 46d
Cleared Mar 23, 1984
STREPTOCOCCUS PNEUMONIAE CONTROL
K840512 · GTY
Scientific Device Laboratory, Inc.
Microbiology · 46d
Cleared Mar 23, 1984
STREPTOCOCCUS GR. B CONTROL
K840513 · GTY
Scientific Device Laboratory, Inc.
Microbiology · 46d
Cleared Mar 23, 1984
NEISSERIA MENINGITIDIS CONTROL
K840514 · LSC
Scientific Device Laboratory, Inc.
Microbiology · 46d
Cleared Mar 23, 1984
DIFFERENTIATION DISKS SPS
K840804 · JTO
Difco Laboratories, Inc.
Microbiology · 28d
Cleared Mar 23, 1984
MICRODASE
K840819 · JTO
Remel Co.
Microbiology · 28d
Cleared Mar 23, 1984
STREP-A-CHEK TUBE
K840884 · JTO
E-Y Laboratories, Inc.
Microbiology · 25d
Cleared Mar 23, 1984
CLOSTRIDIUM DIFFICILE AGAR DEEP &
K840889 · JSI
Remel Co.
Microbiology · 25d
Cleared Mar 23, 1984
BUFFERED CYE AGAR DEEP W/SUPPLEMENTS
K840890 · JSJ
Remel Co.
Microbiology · 25d
Cleared Mar 23, 1984
DIFFERENTIATION DISKS ALA
K840896 · JTO
Difco Laboratories, Inc.
Microbiology · 25d
Cleared Mar 23, 1984
PRESERV TRANSPORT & CULTURE PACK
K840968 · JTW
Preventive Diagnostics Corp.
Microbiology · 17d
Cleared Mar 23, 1984
NIACIN REAGENT STRIP
K840981 · MJD
Remel Co.
Microbiology · 17d
Cleared Mar 23, 1984
PRESERV CARY BLAIR TRANSPORT PACK
K840990 · JTW
Preventive Diagnostics Corp.
Microbiology · 16d
Cleared Mar 23, 1984
PRESERV BUFFERED GLYCEROL SALINE
K840991 · JTW
Preventive Diagnostics Corp.
Microbiology · 16d
Cleared Mar 23, 1984
HEKTOEN ENTERIC AGAR
K841129 · JSI
Anaerobe Systems
Microbiology · 7d
Cleared Mar 23, 1984
TRYPTICASE SOY AGAR W/5% SHEEP BLOOD
K841130 · JSG
Anaerobe Systems
Microbiology · 7d
Cleared Mar 23, 1984
XYLOSE LYSINE DESOXYCHOLATE AGAR
K841131 · JSI
Anaerobe Systems
Microbiology · 7d