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
2185–2208 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Oct 06, 1999
SERAQUEST EB VAC IGM
K990977 · LJN
Quest Intl., Inc.
Microbiology · 197d
Cleared Sep 27, 1999
MODIFICATION OF PASCO MIC AND MIC/ID PANELS
K992420 · JTN
Pasco Laboratories, Inc.
Microbiology · 68d
Cleared Sep 24, 1999
EZ-HBT HELICOBACTER BLOOD TEST
K990931 · MSQ
Metabolic Solutions, Inc.
Microbiology · 189d
Cleared Sep 24, 1999
QUICKVUE INFLUENZA A/B TEST
K991633 · PSZ
Quidel Corp.
Microbiology · 135d
Cleared Sep 24, 1999
BACT/ALERT FN
K992432 · MDB
Organon Teknika Corp.
Microbiology · 65d
Cleared Sep 21, 1999
QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024
K991062 · LSR
Immunetics, Inc.
Microbiology · 174d
Cleared Sep 21, 1999
QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024
K991063 · LSR
Immunetics, Inc.
Microbiology · 174d
Cleared Sep 21, 1999
PASCO MIC AND MIC/ID PANELS, VANCOMYCIN
K992296 · JWY
Pasco Laboratories, Inc.
Microbiology · 76d
Cleared Sep 20, 1999
AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES,...
K992124 · GMQ
Avanti Polar Lipids, Inc.
Microbiology · 89d
Cleared Sep 16, 1999
MODIFICATION TO PASCO MIC AND MIC/ID PANELS (CLINDAMYCIN)
K992143 · JWY
Pasco Laboratories, Inc.
Microbiology · 84d
Cleared Sep 15, 1999
NUCLISENS CMV PP67
K983762 · LIN
Organon Teknika Corp.
Microbiology · 324d
Cleared Sep 03, 1999
IS H. PYLORI IGG ELISA TEST SYSTEM
K990462 · LYR
Columbia Bioscience, Inc.
Microbiology · 203d
Cleared Sep 03, 1999
BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM
K991180 · LSR
Zeus Scientific, Inc.
Microbiology · 148d
Cleared Sep 03, 1999
BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM
K991185 · LSR
Zeus Scientific, Inc.
Microbiology · 148d
Cleared Sep 03, 1999
MUMPS IGG ELISA TEST SYSTEM
K991274 · LJY
Columbia Bioscience, Inc.
Microbiology · 143d
Cleared Sep 03, 1999
PASCO MIC AND MIC/ID PANELS (OFLOXACIN)
K992077 · JTN
Pasco Laboratories, Inc.
Microbiology · 74d
Cleared Sep 03, 1999
PASCO MIC AND MIC/ID PANELS (CEFEPIME)
K992108 · JWY
Pasco Laboratories, Inc.
Microbiology · 73d
Cleared Sep 03, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN...
K992166 · LGC
Zeus Scientific, Inc.
Microbiology · 70d
Cleared Sep 03, 1999
PASCO MIC AND MIC/ID PANELS, LEVOFLOXACIN
K992297 · JTN
Pasco Laboratories, Inc.
Microbiology · 58d
Cleared Sep 03, 1999
BACTALERT FA
K992400 · MDB
Organon Teknika Corp.
Microbiology · 46d
Cleared Sep 03, 1999
BACT/ALERT PF
K992401 · MDB
Organon Teknika Corp.
Microbiology · 46d
Cleared Aug 30, 1999
PASCO MIC AND MIC/ID PANELS
K992059 · JWY
Pasco Laboratories, Inc.
Microbiology · 73d
Cleared Aug 30, 1999
PASCO MIC AND MIC/ID PANELS (CEFUROXIME)
K992076 · JTN
Pasco Laboratories, Inc.
Microbiology · 70d
Cleared Aug 27, 1999
BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12...
K991726 · GTZ
Binax, Inc.
Microbiology · 99d