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
1297–1320 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Mar 29, 2010
BIOPLEX 2200 MMRV IGG
K091616 · OPL
Bio-Rad Laboratories
Microbiology · 299d
Cleared Mar 29, 2010
TELAVANCIN 30 UG, BBL SENSI-DISC
K100722 · JTN
Becton, Dickinson and Company
Microbiology · 14d
Cleared Mar 12, 2010
ELECSYS RUBELLA IGM IMMUNOASSAY
K092322 · LFX
Roche Diagnostics
Microbiology · 220d
Cleared Mar 12, 2010
C. ALBICANS/C. GLABRATA PNA FISH
K092784 · NZS
Advandx, Inc.
Microbiology · 183d
Cleared Mar 12, 2010
LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124
K093815 · OMG
Millipore Corporation
Microbiology · 88d
Cleared Mar 09, 2010
POC-AS10 AUTO SAMPLER
K092817 · MSQ
Otsuka Pharmaceutical Co., Ltd.
Microbiology · 176d
Cleared Mar 02, 2010
CHROMID VRE AGAR, MODEL: REF 43 851
K091025 · JSO
bioMerieux, Inc.
Microbiology · 326d
Cleared Feb 25, 2010
SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC...
K093741 · JWY
Trek Diagnostic Systems, Ltd.
Microbiology · 83d
Cleared Feb 24, 2010
CLEARVIEW EXACT PBP2A TEST, MODEL 891-000
K091766 · MYI
Binax, Inc.
Microbiology · 252d
Cleared Feb 23, 2010
SAS FLUALERT A&B, SAS INFLUENZA A TEST
K100227 · PSZ
Sa Scientific, Inc.
Microbiology · 28d
Cleared Feb 17, 2010
SENSITITRE 18-24HR SUSCEPTIBILITY PLATES
K093865 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 63d
Cleared Jan 26, 2010
MICROSCAN MICROSTREP PLUS, MODEL B1027-201
K091949 · LTT
Siemens Healthcare Diagnostics
Microbiology · 209d
Cleared Jan 19, 2010
C. ALBICANS PNA FISH
K092655 · NZS
Advandx, Inc.
Microbiology · 144d
Cleared Jan 08, 2010
HARDYDISK AST TELAVANCIN,30UG
K093807 · JTN
Hardy Diagnostics
Microbiology · 28d
Cleared Dec 23, 2009
D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT
K093415 · GQS
Diagnostic Hybrids, Inc.
Microbiology · 51d
Cleared Dec 17, 2009
Xpert VanA Assay
K092953 · NIJ
Cepheid
Microbiology · 84d
Cleared Dec 16, 2009
BINAXNOX STAPHYLOCOCCUS AUREUS TEST
K090964 · JWX
Binax, Inc.
Microbiology · 254d
Cleared Dec 16, 2009
IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM
K091361 · LIP
Siemens Healthcare Diagnostics
Microbiology · 222d
Cleared Dec 16, 2009
E.COLI/P. AERUGINOSA PNA FISH
K092236 · JSS
Advandx, Inc.
Microbiology · 146d
Cleared Dec 16, 2009
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
K092445 · JWY
Trek Diagnostic Systems, Ltd.
Microbiology · 128d
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