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
2209–2232 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Oct 14, 1999
PASCO MIC AND MIC/ID PANELS, CHLORAMPHENICOL
K992593 · JTN
Pasco Laboratories, Inc.
Microbiology · 72d
Cleared Oct 13, 1999
PASCO MIC AND MIC/ID PANELS, CEFTRIAXONE
K992562 · JTN
Pasco Laboratories, Inc.
Microbiology · 72d
Cleared Oct 12, 1999
PASCO MIC AND MIC/ID PANELS, MEROPENEM
K992546 · JTN
Pasco Laboratories, Inc.
Microbiology · 74d
Cleared Oct 08, 1999
PASCO MIC AND MIC/ID PANELS, TROVAFLOXACIN
K992507 · JTN
Pasco Laboratories, Inc.
Microbiology · 73d
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