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
3073–3096 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Oct 19, 1994
PASCO MIC AND MIC/ID PANELS
K944517 · JWY
Pasco Laboratories, Inc.
Microbiology · 34d
Cleared Oct 14, 1994
MUMPS STAT
K925209 · LJY
Biowhittaker Molecular Applications,...
Microbiology · 737d
Cleared Oct 07, 1994
VIROTROL TORCH
K942295 · JJY
Blackhawk Biosystems, Inc.
Microbiology · 148d
Cleared Oct 04, 1994
BRAIN HEART INFUSION AGAR
K944554 · JSO
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 18d
Cleared Sep 20, 1994
PROSPECT MICROPLATE ASSAY
K934493 · LLH
Alexon, Inc.
Microbiology · 370d
Cleared Sep 20, 1994
IMMUNOCARD MYCOPLASMA
K934550 · LJZ
Meridian Diagnostics, Inc.
Microbiology · 363d
Cleared Sep 20, 1994
BINAX LEGIONELLA URINARY ANTIGEN EIA
K934965 · MJH
Binax, Inc.
Microbiology · 340d
Cleared Sep 20, 1994
CHLAMYDIA MICROPLATE EIA, CHLAMYDIA MICROPLAE EIA BLOCKING ASSAY
K935393 · LJC
Bio-Rad Laboratories, Inc.
Microbiology · 316d
Cleared Sep 19, 1994
REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG
K935975 · JTN
Remel, Inc.
Microbiology · 280d
Cleared Sep 19, 1994
SYNERGY QUAD
K941443 · JSO
Remel Co.
Microbiology · 179d
Cleared Sep 19, 1994
BHI AGAR WITH VANCOMYCIN
K941444 · JSO
Remel Co.
Microbiology · 179d
Cleared Sep 14, 1994
SWABZYME OXIDASE
K934130 · JTO
E-Y Laboratories, Inc.
Microbiology · 394d
Cleared Sep 09, 1994
GONOCHEK-II, MODIFICATION
K934125 · JTO
E-Y Laboratories, Inc.
Microbiology · 393d
Cleared Sep 09, 1994
CULTURIA MACCONKEY-MUG
K934759 · JXA
Clinical Convenience Products, Inc.
Microbiology · 340d
Cleared Sep 09, 1994
B-LACTAMASE REAGENT TUBES
K940161 · JTO
E-Y Laboratories, Inc.
Microbiology · 240d
Cleared Sep 09, 1994
GONOCHEK II REAGENT TUBES
K940162 · JTO
E-Y Laboratories, Inc.
Microbiology · 240d
Cleared Sep 09, 1994
PROSPECT GIARDIA
K942098 · MHI
Alexon, Inc.
Microbiology · 148d
Cleared Aug 30, 1994
BACT/ALERT FAN AEROBIC CULTURE BOTTLE
K935711 · MDB
Organon Teknika Corp.
Microbiology · 273d
Cleared Aug 26, 1994
STREP-A-CHEK
K934129 · JTO
E-Y Laboratories, Inc.
Microbiology · 379d
Cleared Aug 26, 1994
STREP-A-CHEK(TM) REAGENT STRIPS
K940020 · JTO
E-Y Laboratories, Inc.
Microbiology · 235d
Cleared Aug 26, 1994
EY-20 REAGENT TUBES
K940124 · JTO
E-Y Laboratories, Inc.
Microbiology · 228d
Cleared Aug 24, 1994
MUELLER HINTON AGAR W/OXACILLIN
K941985 · JTZ
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 121d
Cleared Aug 16, 1994
CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM
K932337 · JSM
Medical Packaging Corp.
Microbiology · 459d
Cleared Aug 16, 1994
CULTURE-PAK COLLECTION/TRANSPORT SYSTEM, MODIFIED
K936078 · JSM
Medical Packaging Corp.
Microbiology · 326d