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
1417–1440 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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
Cleared Apr 16, 2008
RAMP INFLUENZA A/B ASSAY
K071591 · PSZ
Response Biomedical Corp.
Microbiology · 310d
Cleared Mar 31, 2008
B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM
K070310 · NTM
Brahms Aktiengesellschaft
Microbiology · 424d
Cleared Mar 20, 2008
SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE
K073653 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 85d
Cleared Mar 13, 2008
SENSITITRE 18-24 SUSCEPTIBILITY PLATE
K073558 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 85d