FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Microbiology ×
7,061 results
1393–1416 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Dec 05, 2008
ELECSYS RUBELLA IGG IMMUNOASSAY
K072617 · LFX
Roche Diagnostics Corp.
Microbiology · 445d
Cleared Dec 05, 2008
LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV
K082049 · LOL
DiaSorin, Inc.
Microbiology · 140d
Cleared Dec 05, 2008
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DOXYCYCLINE (GP) 0.25-16 UG/ML
K082913 · LON
Becton, Dickinson & CO
Microbiology · 66d
Cleared Nov 21, 2008
DIASORIN LIASON RUBELLA IGG ASSAY
K073390 · LFX
DiaSorin, Inc.
Microbiology · 354d
Cleared Nov 20, 2008
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PHOENIX INDUCIBLE MACROLIDE...
K082538 · LON
Becton, Dickinson & CO
Microbiology · 79d
Cleared Nov 18, 2008
LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG
K081685 · MXJ
DiaSorin, Inc.
Microbiology · 154d
Cleared Nov 10, 2008
LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG
K081687 · MYF
DiaSorin, Inc.
Microbiology · 146d
Cleared Nov 07, 2008
PRO HMPV+ ASSAY
K082688 · OEM
Prodesse, Inc.
Microbiology · 53d
Cleared Nov 03, 2008
LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM
K082050 · LOL
DiaSorin, Inc.
Microbiology · 108d
Cleared Oct 24, 2008
SENSITITRE VIZION
K081520 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 147d
Cleared Oct 06, 2008
FLUCONAZOLE 25UG BBL SENSI-DISC
K082271 · JTN
Becton, Dickinson & CO
Microbiology · 56d
Cleared Oct 06, 2008
BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A
K082661 · GTY
Princeton BioMeditech Corp.
Microbiology · 24d
Cleared Oct 02, 2008
VORICONAZOLE 1UG BBL SENSI-DISC
K082272 · JTN
Becton, Dickinson & CO
Microbiology · 52d
Cleared Sep 30, 2008
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL
K080570 · NXD
Centers For Disease Control and...
Microbiology · 214d
Cleared Sep 30, 2008
APPLIED BIOSYSTEMS 7500 FAST DX
K082562 · NSU
Applied Biosystems, Inc.
Microbiology · 26d
Cleared Sep 29, 2008
XPERT MRSA/SA BLOOD CULTURE ASSAY
K082140 · NQX
Cepheid
Microbiology · 61d
Cleared Sep 24, 2008
XPERT MRSA/SA SSTI ASSAY
K080837 · NQX
Cepheid
Microbiology · 183d
Cleared Sep 12, 2008
YEAST TRAFFIC LIGHT PNA FISH
K080719 · JXB
Advandx, Inc.
Microbiology · 183d
Cleared Sep 08, 2008
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST...
K081013 · LRG
Siemens Healthcare Diagnostics
Microbiology · 152d
Cleared Aug 08, 2008
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST -...
K081182 · JWY
Siemens
Microbiology · 105d
Cleared Aug 04, 2008
PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M
K073381 · LJN
Focus Diagnostics, Inc.
Microbiology · 245d
Cleared Jul 28, 2008
PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G
K073382 · LSE
Focus Diagnostics, Inc.
Microbiology · 238d
Cleared Jul 24, 2008
ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML
K081325 · JWY
Ab Biodisk
Microbiology · 73d
Cleared Jul 17, 2008
ADVIA CENTAUR HAVM ASSAY
K081716 · LOL
Siemens Healthcare Diagnostics, Inc.
Microbiology · 29d