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
1513–1536 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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
Cleared Apr 17, 2007
XPERT MRSA
K070462 · NQX
Cepheid
Microbiology · 60d
Cleared Apr 16, 2007
ABBOTT ARCHITECT HAVAB-M
K063329 · LOL
Abbott Laboratories
Microbiology · 164d
Cleared Apr 16, 2007
AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
K070174 · MKZ
Roche Diagnostics Corporation
Microbiology · 88d
Cleared Apr 12, 2007
LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870
K062473 · LSR
DiaSorin, Inc.
Microbiology · 231d
Cleared Mar 21, 2007
ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM
K063186 · LFX
Zeus Scientific, Inc.
Microbiology · 152d
Cleared Mar 19, 2007
BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
K063866 · LIP
Bio-Rad Laboratories
Microbiology · 80d
Not Cleared Mar 16, 2007
XPERT EV, MODEL GXEV-100N-10
DEN070004 · OAI
Cepheid
Microbiology · 4d
Cleared Mar 15, 2007
MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012
K070522 · MJH
Inverness Medical Professional...
Microbiology · 20d
Cleared Mar 14, 2007
ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K070262 · JTN
Oxoid , Ltd.
Microbiology · 47d
Cleared Mar 07, 2007
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MINOCYCLINE (1-32 UG/ML) GRAM...
K063486 · LON
Becton, Dickinson & CO
Microbiology · 110d
Cleared Mar 07, 2007
BD DIRECTIGEN EZ FLU A+B TEST
K063689 · PSZ
Becton, Dickinson & CO
Microbiology · 85d
Cleared Feb 26, 2007
DIASORIN LIAISON VZV IGG
K061820 · LFY
DiaSorin, Inc.
Microbiology · 243d
Cleared Feb 14, 2007
IMMUNOCARD STAT! EHEC, MODEL 751630
K062546 · GMZ
Meridian Bioscience, Inc.
Microbiology · 168d
Cleared Feb 14, 2007
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM (GN) 0.5-64UG/ML
K063824 · LON
Becton, Dickinson & CO
Microbiology · 50d
Cleared Feb 09, 2007
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GN) 0.5-32UG/ML
K063811 · LON
Becton, Dickinson & CO
Microbiology · 49d
Cleared Feb 08, 2007
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CHLORAMPHENICOL...
K063564 · LON
Dade Behring, Inc.
Microbiology · 72d
Cleared Feb 01, 2007
HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G
K062543 · MXJ
Focus Diagnostics, Inc.
Microbiology · 155d
Cleared Jan 29, 2007
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFPODOXIME (GN) 0.125-8UG/ML
K063300 · LON
Becton, Dickinson & CO
Microbiology · 89d
Cleared Jan 25, 2007
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091
K063664 · LSL
Gen-Probe, Inc.
Microbiology · 48d
Cleared Jan 22, 2007
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199
K063451 · MKZ
Gen-Probe, Inc.
Microbiology · 68d