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
1345–1368 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Aug 28, 2009
MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
K092300 · GNW
Diagnostic Hybrids, Inc.
Microbiology · 30d
Cleared Aug 26, 2009
XPECT FLU A & B
K092423 · PSZ
Thermo Fisher Scientific
Microbiology · 19d
Cleared Aug 20, 2009
MODIFICATION TO PROFLU+ ASSAY
K092500 · OCC
Prodesse, Inc.
Microbiology · 6d
Cleared Aug 18, 2009
S. AUREUS PNA FISH
K091827 · NXX
Advandx, Inc.
Microbiology · 60d
Cleared Aug 14, 2009
VITEK 2 GRAM NEGATIVE MEROPENEM
K091899 · LON
bioMerieux, Inc.
Microbiology · 50d
Cleared Aug 12, 2009
MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST
K092223 · PSZ
Binax, Inc.
Microbiology · 20d
Cleared Aug 05, 2009
VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE
K082329 · LSR
Viramed Biotech AG
Microbiology · 356d
Cleared Jul 24, 2009
AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT
K083074 · OAH
Advandx, Inc.
Microbiology · 282d
Cleared Jul 24, 2009
RAMP RSV ASSAY
K091235 · GQG
Response Biomedical Corp.
Microbiology · 88d
Cleared Jul 23, 2009
SAS INFLUENZA A & B TEST
K080380 · PSZ
Sa Scientific, Inc.
Microbiology · 526d
Cleared Jul 22, 2009
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017
K091264 · LTT
Siemens Healthcare Diagnostics
Microbiology · 83d
Cleared Jul 17, 2009
CHROMID MRSA AGAR, MODEL: REF 43 841
K091024 · JSO
bioMerieux, Inc.
Microbiology · 98d
Cleared Jul 09, 2009
XPERT C. DIFFICILE
K091109 · LLH
Cepheid
Microbiology · 84d
Cleared Jul 01, 2009
PLATELIA TOXO IGM KIT MODEL 26211
K090847 · LGD
Bio-Rad Laboratories
Microbiology · 93d
Cleared Jun 25, 2009
E. COLI PNA FISH
K082068 · JSS
Advandx, Inc.
Microbiology · 338d
Cleared Jun 25, 2009
XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112,...
K091667 · OCC
Luminex Molecular Diagnostics, Inc.
Microbiology · 16d
Cleared Jun 18, 2009
VITEK 2 GRAM POSITIVE DAPTOMYCIN
K091126 · LON
bioMerieux, Inc.
Microbiology · 59d
Cleared Jun 08, 2009
SERAQUEST EBV EA-D IGG TEST
K091260 · LSE
Quest Intl., Inc.
Microbiology · 40d
Cleared Jun 05, 2009
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
K090971 · LSL
Becton, Dickinson & CO
Microbiology · 60d
Cleared Jun 04, 2009
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
K090968 · NGZ
Trek Diagnostic Systems, Inc.
Microbiology · 59d
Cleared Jun 02, 2009
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY
K090824 · MKZ
Becton, Dickinson & CO
Microbiology · 68d
Cleared May 28, 2009
IMMUNOCARD STAT CAMPY, MODEL 751530
K090700 · LQP
Meridian Bioscience, Inc.
Microbiology · 72d
Cleared May 27, 2009
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
K090827 · LSL
Becton, Dickinson & CO
Microbiology · 62d
Cleared May 08, 2009
BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION...
K090409 · MXJ
Bio-Rad Laboratories
Microbiology · 79d