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
2569–2592 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jan 22, 1997
A.C.T. I
K965149 · JSM
Remel Co.
Microbiology · 30d
Cleared Jan 22, 1997
A.C.T. IV
K965150 · JSM
Remel Co.
Microbiology · 30d
Cleared Jan 22, 1997
A.C.T. III
K965151 · JSM
Remel Co.
Microbiology · 30d
Cleared Jan 22, 1997
A.C.T. II
K965152 · JSM
Remel Co.
Microbiology · 30d
Cleared Jan 21, 1997
IMMUNOCARD H. PYLORI
K961508 · LYR
Meridian Diagnostics, Inc.
Microbiology · 277d
Cleared Jan 15, 1997
BHI W/VANCOMYCIN AGAR
K964560 · JSO
Hardy Diagnostics
Microbiology · 63d
Cleared Dec 26, 1996
IMAGEN RESPIRATORY SCREEN
K962037 · GNW
Dako Diagnostics , Ltd.
Microbiology · 216d
Cleared Dec 24, 1996
CULTURE COLLECTION AND TRANSPORT SYSTEM, MODIFIED AMIES MEDIA
K964637 · JSM
Medical Packaging Corp.
Microbiology · 35d
Cleared Dec 20, 1996
RUBASCAN CARD TEST
K952721 · LFX
Bd Becton Dickinson Vacutainer...
Microbiology · 554d
Cleared Dec 18, 1996
STREPTOCOCCUS MIC PANEL
K963641 · JWY
Dade Microscan, Inc.
Microbiology · 97d
Cleared Dec 18, 1996
PIPERACILLIN/TAZOBACTAM 4
K964203 · JWY
Ab Biodisk
Microbiology · 77d
Cleared Dec 16, 1996
STREPTOLEX-STAT
K962296 · GTZ
Unipath , Ltd.
Microbiology · 187d
Cleared Dec 16, 1996
INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)
K963296 · LGD
Incstar Corp.
Microbiology · 117d
Cleared Dec 16, 1996
INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)
K963297 · LGD
Incstar Corp.
Microbiology · 117d
Cleared Dec 06, 1996
REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK
K964421 · JTN
Remel, L.P.
Microbiology · 66d
Cleared Nov 29, 1996
GIARDIA CELISA
K963135 · MHI
Techlab, Inc.
Microbiology · 109d
Cleared Nov 27, 1996
GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT
K962217 · MKZ
Gen-Probe, Inc.
Microbiology · 170d
Cleared Nov 27, 1996
PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF...
K964144 · LIO
Para Scientific Co.
Microbiology · 41d
Cleared Nov 21, 1996
BACTEC FUNGAL MEDIUM
K954923 · JTA
Becton Dickinson Diagnostic...
Microbiology · 392d
Cleared Nov 08, 1996
STP SYSTEM PVA WITH ZINC
K963986 · LIO
Sage Products, Inc.
Microbiology · 35d
Cleared Nov 07, 1996
STP SYSTEM - SAF
K964026 · LIO
Sage Products, Inc.
Microbiology · 31d
Cleared Nov 01, 1996
WELLCOLEX E-COLI OI57 ZC60
K962028 · GNA
Murex Diagnostics, Inc.
Microbiology · 162d
Cleared Nov 01, 1996
STP SYSTEM-PVA WITH MERCURY
K964027 · LIO
Sage Products, Inc.
Microbiology · 25d
Cleared Oct 31, 1996
COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY...
K961784 · LQN
Sienna Biotech, Inc.
Microbiology · 182d