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
3025–3048 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Feb 24, 1995
SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP
K944753 · JWY
Radiometer America, Inc.
Microbiology · 151d
Cleared Feb 17, 1995
MICRODILUTION DEVICE FOR DETERMINING GENTAMICIN & STRRPTOMYCIN FOR DETECTION...
K943756 · JWY
Alamar Biosciences, Inc.
Microbiology · 199d
Cleared Feb 17, 1995
BACT/ALERT FAN CULTURE BOTTLE
K944594 · MDB
Organon Teknika Corp.
Microbiology · 151d
Cleared Feb 16, 1995
FAS FASTIDIOUS MIC PANEL
K935485 · JWY
Microtech Medical Systems, Inc.
Microbiology · 458d
Cleared Feb 16, 1995
DRIED GRAM-NEGATIVE CEFPODOXIME
K941030 · LTT
Baxter Diagnostics, Inc.
Microbiology · 349d
Cleared Feb 16, 1995
KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM
K944847 · JSL
Starplex Scientific, Inc.
Microbiology · 139d
Cleared Feb 16, 1995
MODIFIED FOX EXTRA GRAM POSITIVE
K945997 · JWY
Micro-Media Systems, Inc.
Microbiology · 132d
Cleared Feb 10, 1995
QUICKVUE IN-LINE ONE-STEP STREP A CONTROL SWABS (POSITIVE & NEGATIVE SWAB...
K945080 · GTY
Quidel Corp.
Microbiology · 116d
Cleared Feb 08, 1995
LORACARBEF GRAM-NAGATIVE PANELS
K940917 · JWY
Baxter Diagnostics, Inc.
Microbiology · 348d
Cleared Feb 03, 1995
GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX
K941459 · JWY
Baxter Diagnostics, Inc.
Microbiology · 316d
Cleared Feb 02, 1995
GCII AGAR WITH ISOVITALX(R) ENRICHMENT
K945569 · JSO
Becton Dickinson Microbiology Systems
Microbiology · 114d
Cleared Jan 31, 1995
DRIED GRAM NEGATIVE/CEFMETAZOLE
K941317 · JWY
Baxter Diagnostics, Inc.
Microbiology · 319d
Cleared Jan 27, 1995
PROLEX (STREPTOCCAL GROUPING LATEX KIT)
K934383 · GTZ
Pro-Lab, Inc.
Microbiology · 505d
Cleared Jan 27, 1995
BBL CRYSTAL MRSA ID SYSTEM
K941997 · JWY
Becton Dickinson Microbiology Systems
Microbiology · 277d
Cleared Jan 27, 1995
RAPID YEAST PLUS SYSTEM
K943621 · JXB
Innovative Diagnostic Systems, Inc.
Microbiology · 184d
Cleared Jan 17, 1995
PASCO MIC AND MIC/ID PANELS
K946126 · JWY
Pasco Laboratories, Inc.
Microbiology · 33d
Cleared Jan 09, 1995
MICRODILUTION/LORACARBEF PANELS
K942089 · JWY
Baxter Diagnostics, Inc.
Microbiology · 252d
Cleared Jan 09, 1995
DRIED GRAM-POSITIVE MIC/COMBO PANELS/CEFMETAZOLE
K942267 · JWY
Baxter Diagnostics, Inc.
Microbiology · 244d
Cleared Jan 09, 1995
IMAGEN
K943557 · GQS
Dako Diagnostics , Ltd.
Microbiology · 171d
Cleared Dec 22, 1994
BIOMERIEUX HEMOLAB AT III
K934156 · JBQ
Biomerieux Vitek, Inc.
Microbiology · 482d
Cleared Dec 19, 1994
IMX RUBELLA IGM ANTIBODY ASSAY
K931059 · LFX
Abbott Laboratories
Microbiology · 658d
Cleared Dec 19, 1994
ABBOTT CHAGAS ANTIBODY EIA
K933716 · MIU
Abbott Laboratories
Microbiology · 507d
Cleared Dec 19, 1994
PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)
K943317 · LKT
Diagnostic Products Corp.
Microbiology · 161d
Cleared Dec 19, 1994
DISPENS-O-DISC PIPERACILLIN 100 MCG./TAZOBACTAM 10 MCG.
K944275 · JTN
Difco Laboratories, Inc.
Microbiology · 111d