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
1321–1344 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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
Cleared Sep 04, 2009
CLEARVIEW ADVANCED STREP A , MODEL 737-430
K091489 · GTY
Binax, Inc.
Microbiology · 107d
Cleared Sep 01, 2009
BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010
K083744 · MJZ
Binax, Inc.
Microbiology · 259d
Cleared Sep 01, 2009
EK/P. AERUGINOSA PNA FISH
K092393 · JSS
Advandx, Inc.
Microbiology · 27d
Cleared Aug 28, 2009
ELVIS HSV ID AND D3 TYPING TEST SYSTEM
K091753 · GQL
Diagnostic Hybrids, Inc.
Microbiology · 73d