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
2953–2976 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jul 21, 1995
SAS BRUCELLAS ABORTUS ANTISERUM
K952146 · GSM
Sa Scientific, Inc.
Microbiology · 74d
Cleared Jul 18, 1995
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K934458 · JWY
Baxter Diagnostics, Inc.
Microbiology · 673d
Cleared Jul 18, 1995
HM-CAP EIA KIT
K944159 · LYR
Schiff & Co.
Microbiology · 326d
Cleared Jul 18, 1995
SAS BRUCELLA SUIS ANTIGEN
K952139 · GSO
Sa Scientific, Inc.
Microbiology · 71d
Cleared Jul 18, 1995
SAS FEBRILE POSITIVE & NEGATIVE CONTROL ANTISERUM
K952145 · GSN
Sa Scientific, Inc.
Microbiology · 71d
Cleared Jul 17, 1995
SAS FEBRILE ANTIGEN SET
K952131 · GSO
Sa Scientific, Inc.
Microbiology · 70d
Cleared Jul 17, 1995
SAS SALMONELLA H D ANTIGEN
K952135 · GSO
Sa Scientific, Inc.
Microbiology · 70d
Cleared Jul 17, 1995
SAS SALMONELLA H B ANTIGEN
K952136 · GSO
Sa Scientific, Inc.
Microbiology · 70d
Cleared Jul 17, 1995
SAS SALMONELLA H A ANTIGEN
K952137 · GSO
Sa Scientific, Inc.
Microbiology · 70d
Cleared Jul 17, 1995
SAS FRANCISELLA TULARENSIS ANTIGEN
K952138 · GSL
Sa Scientific, Inc.
Microbiology · 70d
Cleared Jul 17, 1995
SAS BRUCELLA MELTIENSIS ANTIGEN
K952140 · GSO
Sa Scientific, Inc.
Microbiology · 70d
Cleared Jul 17, 1995
SAS SALMONELLA O GROUP D ANTIGEN
K952142 · GNC
Sa Scientific, Inc.
Microbiology · 70d
Cleared Jul 17, 1995
SAS BRUCELLA ABORTUS ANTIGEN
K952147 · GSO
Sa Scientific, Inc.
Microbiology · 70d
Cleared Jul 13, 1995
SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATES
K936305 · JWY
Radiometer America, Inc.
Microbiology · 569d
Cleared Jul 11, 1995
VISUWELL SYPHILIS ANTIBODY
K932453 · LIP
Biomira Diagnostics, Inc.
Microbiology · 782d
Cleared Jul 07, 1995
TICARCILLIN/CLAVULANIC ACID 2
K951879 · JWY
Ab Biodisk
Microbiology · 84d
Cleared Jun 30, 1995
CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA
K950196 · JTY
Bioclinical Systems, Inc.
Microbiology · 163d
Cleared Jun 27, 1995
CHOLERA SMART(TM)
K932622 · GSQ
New Horizons Diagnostics Co.
Microbiology · 756d
Cleared Jun 22, 1995
LMD GIARDIA ANTIGEN DETECTION ASSAY
K944871 · MHI
Lmd Laboratories
Microbiology · 262d
Cleared Jun 13, 1995
VIDAS LYME SCREEN II
K943812 · LSR
Biomerieux Vitek, Inc.
Microbiology · 312d
Cleared Jun 13, 1995
ENTEROCOCCUS SCREENING MEDIUM
K951539 · JWY
Becton Dickinson Microbiology Systems
Microbiology · 71d
Cleared Jun 09, 1995
INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT
K946158 · LLM
Incstar Corp.
Microbiology · 183d
Cleared Jun 09, 1995
SAS SALMONELLA H B ANTISERUM
K951069 · GRM
Sa Scientific, Inc.
Microbiology · 93d
Cleared Jun 07, 1995
INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) LGM ELISA KIT
K946157 · LSE
Incstar Corp.
Microbiology · 181d