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
649–672 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Not Cleared Sep 21, 2018
NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET
DEN070001 · PBK
Centers For Disease Control and...
Microbiology · 4266d
Cleared Sep 20, 2018
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
K181205 · PBK
Centers For Disease Control and...
Microbiology · 136d
Cleared Sep 18, 2018
BioSign Flu A+B
K182157 · PSZ
Princeton BioMeditech Corp.
Microbiology · 40d
Cleared Sep 13, 2018
MTS Penicillin 0.002- 32 µg/mL
K181889 · JWY
Liofilchem S. R. L.
Microbiology · 62d
Cleared Aug 31, 2018
LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set
K181464 · LYR
DiaSorin, Inc.
Microbiology · 88d
Cleared Aug 30, 2018
Sofia 2 Lyme FIA, Sofia Lyme Control Set
K173496 · LSR
Quidel Corporation
Microbiology · 290d
Cleared Aug 28, 2018
BD MAX CT/GC/TV 20-Day QC Panel
K181683 · PMN
Microbiologics, Inc.
Microbiology · 63d
Cleared Aug 27, 2018
DENV Detect NS1 ELISA
K181473 · QCU
InBios International, Inc.
Microbiology · 84d
Cleared Aug 23, 2018
ADVIA Centaur Herpes-2 IgG
K181334 · MYF
Biokit, S.A.
Microbiology · 94d
Cleared Aug 23, 2018
ADVIA Centaur Herpes-1 IgG
K181333 · MXJ
Biokit, S.A.
Microbiology · 94d
Cleared Aug 21, 2018
H. PYLORI CHEK™
K181400 · LYR
Techlab, Inc.
Microbiology · 84d
Cleared Aug 21, 2018
H. PYLORI QUIK CHEK
K181379 · LYR
Techlab, Inc.
Microbiology · 89d
Cleared Aug 15, 2018
BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel
K181711 · PMN
Microbiologics, Inc.
Microbiology · 48d
Cleared Aug 15, 2018
Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal...
K181289 · OCC
Cepheid
Microbiology · 91d
Cleared Aug 13, 2018
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
K173498 · OZZ
Diasorin Molecular, LLC
Microbiology · 273d
Cleared Aug 08, 2018
Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in...
K181946 · JWY
Thermo Fisher Scientific
Microbiology · 19d
Cleared Aug 08, 2018
Alere BinaxNOW Influenza A & B Card 2, Alere Reader
K181853 · PSZ
Alere Scarborough, Inc.
Microbiology · 28d
Cleared Jul 31, 2018
MTS Plazomicin 0.016-256 µg/mL
K181708 · JWY
Liofilchem S. R. L.
Microbiology · 33d
Cleared Jul 30, 2018
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B...
K181736 · OZE
Centers For Disease Control and...
Microbiology · 28d
Cleared Jul 30, 2018
ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control
K181213 · LFZ
Siemens Healthcare Diagnostics, Inc.
Microbiology · 84d
Cleared Jul 27, 2018
Panther Fusion GBS Assay
K181156 · NJR
Diagenode
Microbiology · 87d
Cleared Jul 24, 2018
Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal...
K180218 · OCC
Cepheid
Microbiology · 180d
Cleared Jul 16, 2018
Atellica IM BRAHMS Procalcitonin (PCT)
K181002 · PMT
Siemens Healthcare Diagnostics, Inc.
Microbiology · 91d
Cleared Jul 15, 2018
Solana Bordetella Complete Assay
K181029 · OZZ
Quidel Corporation
Microbiology · 88d