FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Microbiology ×
7,061 results
1345–1368 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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
Cleared May 05, 2009
GBS PNA FISH
K082612 · OAH
Advandx, Inc.
Microbiology · 238d
Cleared May 05, 2009
ELECSYS RUBELLA IGG CALCHECK
K090311 · JJX
Roche Diagnostics
Microbiology · 88d
Cleared May 01, 2009
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST
K083088 · OCC
Nanosphere, Inc.
Microbiology · 197d
Cleared Apr 16, 2009
PROGASTRO CD ASSAY
K090239 · LLH
Prodesse, Inc.
Microbiology · 73d
Cleared Apr 15, 2009
ORTHO T. CRUZI ELISA TEST SYSTEM
K072732 · MIU
Ortho-Clinical Diagnostics, Inc.
Microbiology · 567d
Cleared Apr 08, 2009
AVC A/H5N1 FLU TEST
K083278 · OMS
Arbor Vita Corportation
Microbiology · 152d