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
1345–1368 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Dec 15, 2009
BD GENEOHM MRSA ACP ASSAY
K093346 · NQX
Bd Diagnostics (Geneohm Sciences, Inc.)
Microbiology · 50d
Cleared Dec 04, 2009
D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT
K093233 · OMG
Diagnostic Hybrids, Inc.
Microbiology · 51d
Cleared Nov 25, 2009
VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS
K092693 · LSR
Viramed Biotech AG
Microbiology · 84d
Cleared Nov 23, 2009
S. AUREUS/CNS PNA FISH, MODEL KT005
K092166 · NXX
Advandx, Inc.
Microbiology · 125d
Cleared Nov 20, 2009
PROPARAFLU+ASSAY
K091053 · OOU
Prodesse, Inc.
Microbiology · 221d
Cleared Nov 17, 2009
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM
K093337 · OCC
Nanosphere, Inc.
Microbiology · 22d
Cleared Nov 13, 2009
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY
K091724 · MKZ
Becton, Dickinson & CO
Microbiology · 155d
Cleared Nov 13, 2009
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
K091730 · LSL
Becton, Dickinson & CO
Microbiology · 155d
Cleared Nov 10, 2009
ELECSYS TOXO IGG CALCHECK 5
K092888 · JJX
Roche Diagnostics Corp.
Microbiology · 50d
Cleared Nov 09, 2009
DENSICHECK PLUS
K093224 · LON
bioMerieux, Inc.
Microbiology · 26d
Cleared Nov 02, 2009
ETEST VORICONAZOLE 0.002-32 UG/ML
K082534 · NGZ
Ab Biomerieux
Microbiology · 426d
Cleared Oct 30, 2009
ELECSYS RUBELLA IGGA CALCHECK 5
K092585 · JJX
Roche Diagnostics
Microbiology · 67d
Cleared Oct 29, 2009
MONOLISA ANTI-HAV IGM EIA
K092353 · LOL
Bio-Rad Laboratories, Inc.
Microbiology · 86d
Cleared Oct 29, 2009
MONOLISA ANTI-HAV EIA
K092355 · LOL
Bio-Rad Laboratories, Inc.
Microbiology · 86d
Cleared Oct 23, 2009
MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025
K092919 · LON
Siemens Healthcare Diagnostics
Microbiology · 30d
Cleared Oct 21, 2009
D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT
K092882 · GNW
Diagnostic Hybrids, Inc.
Microbiology · 33d
Cleared Oct 21, 2009
VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST
K092957 · OCC
Nanosphere, Inc.
Microbiology · 26d
Cleared Oct 21, 2009
MODIFICATION TO: RAMP INFLUENZA A/B ASSAY
K093116 · PSZ
Response Biomedical Corp.
Microbiology · 19d
Cleared Oct 09, 2009
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (RVNATSP)
K092566 · OCC
Nanosphere, Inc.
Microbiology · 50d
Cleared Sep 25, 2009
OSOM INFLUENZA A&B TEST , MODEL PN190
K092633 · PSZ
Genzyme Corporation
Microbiology · 29d
Cleared Sep 15, 2009
QUICKVUE INFLUENZA A+B TEST
K092698 · PSZ
Quidel Corp.
Microbiology · 13d
Cleared Sep 11, 2009
DENSICHEK PLUS
K083536 · LON
bioMerieux, Inc.
Microbiology · 287d
Cleared Sep 11, 2009
D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT
K091171 · OMG
Diagnostic Hybrids, Inc.
Microbiology · 142d
Cleared Sep 11, 2009
TRU FLU, MODEL 751230
K092553 · PSZ
Meridian Bioscience, Inc.
Microbiology · 22d