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
5665–5688 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Feb 03, 1984
CONTACT-K APTT REAGENT
K834086 · GGN
Pacific Hemostasis
Microbiology · 67d
Cleared Feb 03, 1984
IMMUNO-CRP
K834390 · DCN
Immunostics Co., Inc.
Microbiology · 51d
Cleared Feb 03, 1984
IMMUNO-RA
K834391 · DHR
Immunostics Co., Inc.
Microbiology · 51d
Cleared Feb 03, 1984
MUELLER-HINTON AGAR PLATE
K834421 · JTZ
Otisville Biotech, Inc.
Microbiology · 50d
Cleared Feb 03, 1984
DNASE AGAR W/TOLUDINE BLUE PLATE
K840071 · JSH
Otisville Biotech, Inc.
Microbiology · 25d
Cleared Feb 03, 1984
ESCULIN AGAR PLATE
K840073 · JSH
Otisville Biotech, Inc.
Microbiology · 25d
Cleared Feb 03, 1984
TRYPTICASE SOY BROTH TUBE
K840075 · JSG
Otisville Biotech, Inc.
Microbiology · 25d
Cleared Feb 03, 1984
THIOGLYCOLLATE MEDIUM TUBE
K840077 · JSG
Otisville Biotech, Inc.
Microbiology · 25d
Cleared Jan 31, 1984
ANA TRANS TUBE & SWABS STERILE PACK
K834357 · JSL
Anaerobe Systems
Microbiology · 49d
Cleared Jan 30, 1984
BILE ESCULIN AGAR PLATE
K840068 · JSH
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Jan 30, 1984
ANAEROBIC AGAR PLATE
K840069 · JSG
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Jan 30, 1984
EGG YOLK AGAR PLATE
K840070 · JSH
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Jan 30, 1984
BORDET GENGOU AGAR PLATE
K840072 · JSG
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Jan 30, 1984
SABOURAUD DEXTROSE AGAR TUBE
K840078 · JSJ
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Jan 30, 1984
PRESERV MF FIXATIVE 15ML
K840086 · LIO
Preventive Diagnostics Corp.
Microbiology · 20d
Cleared Jan 30, 1984
GC-TECT
K840159 · JTY
Uti-Tect, Inc.
Microbiology · 17d
Cleared Jan 27, 1984
TSA
K834324 · JSG
Hardy Media
Microbiology · 49d
Cleared Jan 27, 1984
ACETAMIDE AGAR SLANTS
K834509 · JSH
Bd Becton Dickinson Vacutainer...
Microbiology · 37d
Cleared Jan 25, 1984
PUMP INFUSION WEARABLE INFUSION PUMP
K833966 · JSJ
Oximetrix, Inc.
Microbiology · 70d
Cleared Jan 17, 1984
CAMPY BRUCELLA AGAR PLATE
K834417 · JSJ
Otisville Biotech, Inc.
Microbiology · 33d
Cleared Jan 17, 1984
CDC ANAEROBE BLOOD AGAR PLATE
K834418 · JSG
Otisville Biotech, Inc.
Microbiology · 33d
Cleared Jan 17, 1984
CTA MEDIUM TUBE
K834425 · JSG
Otisville Biotech, Inc.
Microbiology · 33d
Cleared Jan 17, 1984
LOEFFLER MEDIUM TUBE
K834426 · JSG
Otisville Biotech, Inc.
Microbiology · 33d
Cleared Jan 17, 1984
THIOGEL MEDIUM TUBE
K834427 · JSG
Otisville Biotech, Inc.
Microbiology · 33d