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
1225–1248 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Sep 27, 2011
VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN
K112129 · LON
bioMerieux, Inc.
Microbiology · 63d
Cleared Sep 22, 2011
SENSITITRE OPTIREAD
K110583 · LRG
Trek Diagnostic Systems, Ltd.
Microbiology · 205d
Cleared Sep 15, 2011
VITEK 2 STRPTOCOCCUS AMPICILLIN
K112075 · LON
bioMerieux, Inc.
Microbiology · 57d
Cleared Sep 13, 2011
JBAIDS INFLUENZA A&B DETECTION KIT
K111775 · OCC
U.S. Army Medical Material...
Microbiology · 82d
Cleared Sep 13, 2011
JBAIDS INFLUENZA A SUBTYPING KIT
K111778 · OQW
U.S Army Medical Materiel Development...
Microbiology · 82d
Cleared Sep 01, 2011
XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1)
K112199 · OCC
Luminex Molecular Diagnostics, Inc.
Microbiology · 31d
Cleared Aug 26, 2011
AUTOREADER 2
K103532 · LRG
Trek Diagnostic Systems
Microbiology · 268d
Cleared Aug 25, 2011
VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY
K101234 · OWF
Ventana Medical Systems, Inc.
Microbiology · 479d
Cleared Aug 23, 2011
BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM,...
K111072 · OPL
Bio-Rad Laboratories
Microbiology · 127d
Cleared Aug 23, 2011
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
K111507 · OQW
Centers For Disease Control and...
Microbiology · 83d
Cleared Aug 18, 2011
GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK
K103673 · MHI
Techlab Inc., Corporate Research Center
Microbiology · 245d
Cleared Aug 18, 2011
SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND...
K111429 · JWY
Trek Diagnostic Systems, Ltd.
Microbiology · 87d
Cleared Aug 12, 2011
VITEK 2 AST-ST LINEZOLID
K111599 · LON
bioMerieux, Inc.
Microbiology · 65d
Cleared Aug 04, 2011
LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER
K111387 · OCC
Iquum, Inc.
Microbiology · 79d
Cleared Aug 04, 2011
MICROSCAN(R) MICROSTREP PLUS(R)
K111677 · LRG
Siemens Healthcare Diagnostics, Inc.
Microbiology · 50d
Cleared Aug 03, 2011
MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT
K111527 · OQO
Eragen Biosciences, Inc.
Microbiology · 63d
Cleared Aug 01, 2011
SYPHILIS HEALTH CHECK
K102400 · LIP
Diagnostics Direct, LLC
Microbiology · 342d
Cleared Jul 20, 2011
CRAG LATERAL FLOW ASSAY (CRAG LFA)
K102286 · GMD
Immuno-Mycologics, Inc.
Microbiology · 342d
Cleared Jul 20, 2011
MICROSCAN (R) MICROSTREP PLUS (R) PANELS
K111205 · LRG
Siemens Healthcare Diagnostics, Inc.
Microbiology · 82d
Cleared Jul 19, 2011
ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102
K101407 · MIZ
Immuno-Mycologics, Inc.
Microbiology · 426d
Cleared Jul 01, 2011
XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST
K103776 · OCC
Luminex Molecular Diagnostics, Inc.
Microbiology · 186d
Cleared Jun 27, 2011
PROFLU+ ASSAY
K110968 · OCC
Gen-Probe Prodesse, Inc.
Microbiology · 82d
Cleared Jun 22, 2011
THE SENSITITRE AIM
K103456 · LIE
Trek Diagnostic Systems
Microbiology · 210d
Cleared Jun 22, 2011
MICROSCAN MICROSTEP
K111394 · LTT
Siemens Healthcare Diagnostics, Inc.
Microbiology · 35d