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
1489–1512 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Oct 15, 2007
VITEK 2 GRAM POSITIVE VANCOMYCIN
K072668 · LON
bioMerieux, Inc.
Microbiology · 24d
Cleared Oct 11, 2007
VIDAS B.R.A.H.M.S. PCT ASSAY
K071146 · NTM
bioMerieux, Inc.
Microbiology · 170d
Cleared Oct 05, 2007
PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G
K071511 · MXJ
Focus Diagnostics, Inc.
Microbiology · 123d
Cleared Oct 02, 2007
MODIFICATION TO BIOSTAR OIA SHIGATOX
K071799 · GNA
Iverness Medical Professional...
Microbiology · 92d
Cleared Sep 24, 2007
DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT
K063675 · LJP
Diagnostic Hybrids, Inc.
Microbiology · 287d
Cleared Sep 24, 2007
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MINOCYCLINE (GP) 1-32 UG/ML
K070809 · LON
Becton, Dickinson & CO
Microbiology · 182d
Cleared Sep 24, 2007
HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950
K071510 · MXJ
Focus Diagnostics, Inc.
Microbiology · 112d
Cleared Sep 21, 2007
DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL...
K063798 · GQN
Diagnostic Hybrids, Inc.
Microbiology · 273d
Cleared Sep 13, 2007
MRSASELECT
K070361 · JSO
Bio-Rad
Microbiology · 218d
Cleared Sep 12, 2007
VITEK 2 GRAM NEGATIVE LEVOFLOXACIN
K072038 · LON
bioMerieux, Inc.
Microbiology · 49d
Cleared Aug 30, 2007
DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000
K070206 · GQW
Diagnostic Hybrids, Inc.
Microbiology · 220d
Cleared Aug 20, 2007
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW...
K071316 · LRG
Dade Behring, Inc.
Microbiology · 102d
Cleared Aug 20, 2007
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW...
K071317 · LON
Dade Behring, Inc.
Microbiology · 102d
Cleared Aug 20, 2007
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, AMPICILLIN-SULBACTAM (GN)...
K071623 · LON
Becton, Dickinson & CO
Microbiology · 67d
Cleared Jul 30, 2007
COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET...
K070062 · LIO
Diesse Diagnostica Senese S.P.A.
Microbiology · 206d
Cleared Jul 18, 2007
DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM
K070346 · LON
Dade Behring, Inc.
Microbiology · 162d
Cleared Jul 05, 2007
ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM
K070317 · LFY
Zeus Scientific, Inc.
Microbiology · 153d
Cleared Jun 28, 2007
EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT
K061239 · MYF
Euroimmun Us, LLC
Microbiology · 421d
Cleared Jun 28, 2007
SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST
K061496 · MJH
Sa Scientific , Ltd.
Microbiology · 393d
Cleared Jun 26, 2007
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS WITH TETRACYCLINE
K071268 · LON
Dade Behring, Inc.
Microbiology · 50d
Not Cleared Jun 13, 2007
BINAX NOW MALARIA TEST
DEN070006 · OAX
Inverness Medical Professional...
Microbiology · 82d
Cleared May 21, 2007
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS
K071076 · LON
Dade Behring, Inc.
Microbiology · 35d
Cleared May 21, 2007
MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM
K071188 · NHT
Idaho Technology, Inc.
Microbiology · 21d
Cleared May 11, 2007
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CLINDAMYCIN
K070860 · LON
Dade Behring, Inc.
Microbiology · 44d