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
2881–2904 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Oct 26, 1995
SAS SALMONELLA O GROUP A ANTIGEN
K953841 · GNC
Sa Scientific, Inc.
Microbiology · 71d
Cleared Oct 26, 1995
SAS SALMONELLA H C ANTIGEN
K953842 · GNC
Sa Scientific, Inc.
Microbiology · 71d
Cleared Oct 26, 1995
SAS SALMONELLA O GROUP F ANTIGEN
K953843 · GNC
Sa Scientific, Inc.
Microbiology · 71d
Cleared Oct 26, 1995
SAS SALMONELLA VI ANTIGEN
K953844 · GNC
Sa Scientific, Inc.
Microbiology · 71d
Cleared Oct 26, 1995
SAS SALMONELLA O GROUP C ANTIGEN
K953846 · GNC
Sa Scientific, Inc.
Microbiology · 71d
Cleared Oct 26, 1995
SAS SALMONELLA O GROUP B ANTIGEN
K953848 · GNC
Sa Scientific, Inc.
Microbiology · 71d
Cleared Oct 20, 1995
DIRECTIGEN 1-2-3 GROUP A STREP TEST
K951542 · GTZ
Bd Becton Dickinson Vacutainer...
Microbiology · 200d
Cleared Oct 20, 1995
OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT
K953437 · GTQ
Olympus America, Inc.
Microbiology · 91d
Cleared Oct 20, 1995
QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION)
K954257 · GTZ
Quidel Corp.
Microbiology · 85d
Cleared Oct 17, 1995
MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM
K950073 · GSA
Shared Systems, Inc.
Microbiology · 281d
Cleared Oct 17, 1995
MEDTEC AUTOBLOT 2000
K951753 · JQW
Medtec, Inc.
Microbiology · 183d
Cleared Oct 16, 1995
CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST
K951754 · JSO
Hardy Diagnostics
Microbiology · 182d
Cleared Oct 07, 1995
CHLAMYDIA OIA
K951010 · LJC
Biostar, Inc.
Microbiology · 215d
Cleared Oct 07, 1995
JUSTONE
K951240 · JWY
Radiometer America, Inc.
Microbiology · 222d
Cleared Oct 07, 1995
HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE
K951241 · JWY
Radiometer America, Inc.
Microbiology · 222d
Cleared Oct 07, 1995
FOX FASTIDIOUS TEST PANELS
K953422 · JWY
Micro-Media Systems, Inc.
Microbiology · 92d
Cleared Oct 06, 1995
TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM
K953284 · MHI
Trend Scientific, Inc.
Microbiology · 85d
Cleared Sep 27, 1995
E. COLI 0157 ELISA STOOL ASSAY
K942705 · GMZ
Lmd Laboratories
Microbiology · 476d
Cleared Sep 25, 1995
EBV-VCA IGM ELISA TEST STSTEM
K944449 · LSE
Zeus Scientific, Inc.
Microbiology · 378d
Cleared Sep 19, 1995
EBNA IGG ELISA TEST
K935730 · LLM
Gull Laboratories, Inc.
Microbiology · 657d
Cleared Sep 15, 1995
EBV-EA(D) IGG ELISA TEST
K940093 · LSE
Gull Laboratories, Inc.
Microbiology · 616d
Cleared Sep 12, 1995
POLIOVIRUS 3 MONOCLONAL ANTIBODY
K940017 · GOE
Light Diagnostics
Microbiology · 616d
Cleared Sep 12, 1995
POLIOVIRUS BLEND MONOCLONAL ANTIBODIES
K940026 · GOE
Light Diagnostics
Microbiology · 617d
Cleared Sep 12, 1995
ENTEROVIRUS BLEND MONOCLONAL ANTIBODIES
K940027 · GOE
Chemicon Intl., Inc.
Microbiology · 617d