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
5041–5064 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Aug 28, 1985
ORTHO VIRAL TRANSPORT
K853500 · JSM
Ortho Diagnostic Systems, Inc.
Microbiology · 8d
Cleared Aug 22, 1985
LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT
K852237 · LHL
Genetic Systems Corp.
Microbiology · 92d
Cleared Aug 22, 1985
NEWPORT MEDIA TRANSFER CONTAINER
K852532 · KJA
Newport Bio Systems
Microbiology · 69d
Cleared Aug 20, 1985
TOLVIDINE RED UNHEATED SERUM SYPHILLIS CARD TEST
K852751 · GMQ
Preco, Inc.
Microbiology · 53d
Cleared Aug 20, 1985
ASO SLIDE EIKEN
K853276 · GTQ
Syn-Kit, Inc.
Microbiology · 15d
Cleared Aug 19, 1985
VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010
K851504 · GMP
Ncs Diagnostics, Inc.
Microbiology · 126d
Cleared Aug 19, 1985
RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT
K852185 · LKT
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 91d
Cleared Aug 19, 1985
GENERAL DIAGNOSTICS CEFTAZIDIME 30 MCG SUSC DISK
K852689 · JTN
Warner-Lambert Co.
Microbiology · 55d
Cleared Aug 19, 1985
CEFTAZIDIME 30MCG. SENI-DISC
K852873 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 42d
Cleared Aug 19, 1985
GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISK
K852967 · JTN
Warner-Lambert Co.
Microbiology · 35d
Cleared Aug 19, 1985
CARIESCREEN - SM
K852987 · JSJ
Pharma-Medica of Scandinavia, Ltd.
Microbiology · 35d
Cleared Aug 19, 1985
RAPI - STAPH
K852997 · JWX
Advanced Medical Technology, Inc.
Microbiology · 35d
Cleared Aug 19, 1985
APL LEVINE EMB AGAR
K853225 · JSI
Apl Medical Supplies
Microbiology · 18d
Cleared Aug 19, 1985
APL BIGGY AGAR(NICKERSON)
K853226 · JSI
Apl Medical Supplies
Microbiology · 18d
Cleared Aug 19, 1985
APL PHENYLETHYL ALCOHOL AGAR(WITH 5% SHEEP BLOOD)
K853227 · JSJ
Apl Medical Supplies
Microbiology · 18d
Cleared Aug 19, 1985
APL SALMONELLA-SHIGELLA AGAR
K853228 · JSI
Apl Medical Supplies
Microbiology · 18d
Cleared Aug 19, 1985
APL 6.5% SODIUM CHLORIDE BROTH
K853229 · JSI
Apl Medical Supplies
Microbiology · 18d
Cleared Aug 19, 1985
APL MYCOBIOTIC AGAR
K853230 · JSJ
Apl Medical Supplies
Microbiology · 18d
Cleared Aug 19, 1985
APL SABOURAUD DEXTROSE AGAR
K853231 · JSJ
Apl Medical Supplies
Microbiology · 18d
Cleared Aug 19, 1985
APL MANNITOL SALT AGAR
K853232 · JSI
Apl Medical Supplies
Microbiology · 18d
Cleared Aug 19, 1985
APL CHOCOLATE AGAR
K853233 · KZI
Apl Medical Supplies
Microbiology · 18d
Cleared Aug 19, 1985
APL MACCONKEY AGAR
K853234 · JSI
Apl Medical Supplies
Microbiology · 18d
Cleared Aug 19, 1985
APL HEKTOEN ENTERIC AGAR
K853235 · JSI
Apl Medical Supplies
Microbiology · 18d
Cleared Aug 19, 1985
APL TSA WITH 5% SHEEP BLOOD
K853236 · KZI
Apl Medical Supplies
Microbiology · 18d