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
1321–1344 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared May 13, 2010
IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM...
K100433 · LKQ
Siemens Healthcare Diagnostics
Microbiology · 86d
Cleared May 12, 2010
MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711
K100336 · OQO
Eragen Biosciences
Microbiology · 96d
Cleared May 10, 2010
CLEARVIEW EXACT II INFLUENZA A & B TEST
K092349 · PSZ
Inverness Medical, Inc.
Microbiology · 279d
Cleared Apr 14, 2010
BINAXNOW PBP2A TEST, MODEL 890-000
K090301 · MYI
Binax, Inc.
Microbiology · 432d
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