Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Microbiology ×
7,095 results
1441–1464 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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
Cleared Jul 10, 2008
ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT
K080739 · MKZ
Abbott Molecular, Inc.
Microbiology · 115d
Cleared Jun 26, 2008
PLATELIA LYME IGM
K081362 · LSR
Bio-Rad
Microbiology · 42d
Cleared Jun 25, 2008
XTAG RESPIRATORY VIRAL PANEL
K081483 · OCC
Luminex Molecular Diagnostics, Inc.
Microbiology · 28d
Cleared Jun 23, 2008
NUCLISENS EASYQ ENTEROVIRUS SYSTEM
K063261 · OAI
bioMerieux, Inc.
Microbiology · 602d
Cleared Jun 13, 2008
D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT
K081164 · LIN
Diagnostic Hybrids, Inc.
Microbiology · 50d
Cleared Jun 13, 2008
MRSASELECT - EXTENDED INCUBATION
K081212 · JSO
Bio-Rad
Microbiology · 45d
Cleared Jun 11, 2008
VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY
K080931 · LLH
bioMerieux, Inc.
Microbiology · 70d
Cleared Jun 09, 2008
ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG
K073501 · LGD
Roche Diagnostics Corp.
Microbiology · 179d
Cleared May 30, 2008
ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM
K072178 · MXJ
Zeus Scientific, Inc.
Microbiology · 298d
Cleared May 23, 2008
ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC
K080869 · LGD
Beckman Coulter, Inc.
Microbiology · 53d
Cleared May 12, 2008
DORIPENEM 10UG BBL SENSI-DISC
K080998 · JTN
Becton, Dickinson & CO
Microbiology · 35d
Cleared May 08, 2008
PLATELIA LYME IGG ASSAY
K080012 · LSR
Bio-Rad
Microbiology · 126d
Cleared May 02, 2008
MODIFICATION TO PROFLU+ ASSAY
K081030 · OCC
Prodesse, Inc.
Microbiology · 21d
Cleared Apr 30, 2008
VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE
K080201 · LON
bioMerieux, Inc.
Microbiology · 93d