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
4609–4632 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Mar 20, 1987
NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST
K870117 · JSX
Pro-Lab, Inc.
Microbiology · 67d
Cleared Mar 19, 1987
CANDIDATE(R) SUPER
K863499 · LRF
Mercia Diagnostics , Ltd.
Microbiology · 191d
Cleared Mar 17, 1987
NORFLOXACIN 10 MCG SENSI DISC
K864756 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 102d
Cleared Mar 17, 1987
NORFLOXACIN 10 MCG SUSCEPTIBILITY DISK
K864848 · JTN
Organon Teknika Corp.
Microbiology · 97d
Cleared Mar 17, 1987
IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT
K870089 · GTJ
Microscan Div. Baxter Healthcare Corp.
Microbiology · 67d
Cleared Mar 17, 1987
NORFLOXACIN 10 MCG SENSITIVITY DISKS
K870348 · JTN
Difco Laboratories, Inc.
Microbiology · 48d
Cleared Mar 17, 1987
AZTREONAM 30 MCG SUSCEPTIBILITY DISK
K870870 · JTN
Organon Teknika Corp.
Microbiology · 14d
Cleared Mar 16, 1987
(MERIFLUOR)TM-CRYPTOSPORIDIUM
K870171
Meridian Diagnostics, Inc.
Microbiology · 61d
Cleared Mar 12, 1987
RICKETTSIAL IGG AND IGM IFA KIT
K864110 · GPN
Hillcrest Biologicals
Microbiology · 142d
Cleared Mar 12, 1987
MODIFIED IMAGEN(TM) CHLAMYDIA TEST
K864539 · LJP
Boots-Celltech Diagnostics, Inc.
Microbiology · 113d
Cleared Mar 10, 1987
OCEAN SCIENTIFIC VDRL TEST
K864731 · GMQ
Ocean Scientific, Inc.
Microbiology · 96d
Cleared Mar 10, 1987
DIRECTIGEN MENINGITIS COMBO TEST & (B) STREP TEST
K870155 · GTZ
Bd Becton Dickinson Vacutainer...
Microbiology · 56d
Cleared Mar 05, 1987
AZTREONAM 30 MCG SENSITIVITY DISKS
K870347 · JTN
Difco Laboratories, Inc.
Microbiology · 36d
Cleared Feb 26, 1987
ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL
K864752 · GTY
Abbott Laboratories
Microbiology · 83d
Cleared Feb 26, 1987
SPOTTEST PYR REAGENT
K870449 · JTO
Difco Laboratories, Inc.
Microbiology · 23d
Cleared Feb 26, 1987
CULTURIA MACCONKEY-MUG/MODIFIED TSA SYSTEMS
K870502 · JSI
Clinical Convenience Products, Inc.
Microbiology · 22d
Cleared Feb 25, 1987
MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT SPECI. TEST
K864888 · LJP
Syva Co.
Microbiology · 75d
Cleared Feb 20, 1987
API UNISCEPT (TM) KB
K864891 · JWY
Analytical Products, Inc.
Microbiology · 67d
Cleared Feb 20, 1987
ACCUPOINT TOXO
K865068 · LGD
Syva Co.
Microbiology · 53d
Cleared Feb 19, 1987
MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT
K864565 · GQH
Serono Diagnostics, Inc.
Microbiology · 92d
Cleared Feb 13, 1987
UTISCREEN(R) BACTERIAL ATP TEST
K864202 · JXA
Los Alamos Diagnostics
Microbiology · 109d
Cleared Feb 13, 1987
AZTREONAM 30 MCG. SENSI-DISC
K865034 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 52d
Cleared Feb 13, 1987
P4802 BEA
K870339 · JSI
Lakewood Biochemical Co., Inc.
Microbiology · 16d
Cleared Feb 13, 1987
Z2017, BEA/CNA 5%SB BIPLATE
K870340 · JSI
Lakewood Biochemical Co., Inc.
Microbiology · 16d