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
1201–1224 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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
Cleared May 25, 2011
SMART LEISH, MODEL LGM1-050
K081868 · OUZ
U.S. Army Medical Research Institute...
Microbiology · 1057d
Cleared May 20, 2011
NUCLISENS EASYQ MRSA
K102740 · NQX
bioMerieux, Inc.
Microbiology · 240d
Cleared May 20, 2011
JBAIDS Q FEVER DETECTION KIT
K103207 · OVF
Idaho Technology, Inc.
Microbiology · 200d
Cleared May 20, 2011
ZEUS ELISA HSV GG-2 IGG TEST SYSTEM
K103603 · MYF
Zeus Scientific, Inc.
Microbiology · 163d
Cleared May 18, 2011
VIDAS TOXO IGG AVIDITY
K101946 · LGD
bioMerieux, Inc.
Microbiology · 310d
Cleared May 17, 2011
RPS ADENO DETECTOR PLUS
K110722 · GOD
Rapid Pathogen Screening, Inc.
Microbiology · 63d
Cleared May 16, 2011
ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML
K102535 · JWY
Biomerieux S.A.
Microbiology · 255d
Cleared May 05, 2011
KEYPATH(TM) MRSA/MSSA BLOOD CULTURE TEST- BT
K102342 · OUS
Microphage, Inc.
Microbiology · 260d
Cleared May 04, 2011
ADVIA CENTAUR TOXOPLASMA IGG (TOXO G)
K102681 · LGD
Siemens Healthcare Diagnostics, Inc.
Microbiology · 229d
Cleared May 04, 2011
HARDYCHROM MRSA
K102922 · JSO
Hardy Diagnostics
Microbiology · 215d