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
1465–1488 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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
Cleared May 03, 2007
MONOLISA ANTI-HAV EIA
K063318 · LOL
Bio-Rad Laboratories
Microbiology · 182d
Cleared May 03, 2007
MONOLISA ANTI-HAV IGM EIA
K063319 · LOL
Bio-Rad Laboratories
Microbiology · 182d
Cleared Apr 23, 2007
QUICK VUE RSV TEST, MODELS 20193, 20199
K070747 · GQG
Quidel Corp.
Microbiology · 35d
Cleared Apr 17, 2007
AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
K070172 · LSL
Roche Diagnostics Corporation
Microbiology · 89d