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
5089–5112 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jul 15, 1985
IDENTICULT-AE
K852666 · JTO
Scott Laboratories, Inc.
Microbiology · 21d
Cleared Jul 12, 1985
CELLMATICS HERPES SIMPLEX VIRUS DETECT-SYS
K851372 · GQL
Difco Laboratories, Inc.
Microbiology · 95d
Cleared Jul 12, 1985
CLED AGAR
K852578 · JSH
American Laboratory Supply, Inc.
Microbiology · 24d
Cleared Jul 09, 1985
ABBOTT TOXO-M EIA DIAGNOSTIC KIT
K850567 · LGD
Abbott Laboratories
Microbiology · 147d
Cleared Jul 09, 1985
DERM-KIT
K852480 · JSI
Culture Kits, Inc.
Microbiology · 28d
Cleared Jul 08, 1985
LEGIONELLA CULTURE CONFIRMATIN KIT
K851271 · GRO
Gen-Probe, Inc.
Microbiology · 98d
Cleared Jul 05, 1985
LATEX AGGLUTINATION TEST
K851132 · GTZ
New Horizons Diagnostics Co.
Microbiology · 106d
Cleared Jun 27, 1985
SERUM TRANSPORT VIALS, T25/SC, TZ10/SC
K851506 · JKA
Ncs Diagnostics, Inc.
Microbiology · 73d
Cleared Jun 21, 1985
ELISA FOR HERPES SIMPLEX VIRUS
K843077 · LGC
Scientific Research
Microbiology · 319d
Cleared Jun 21, 1985
SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT
K851033 · LJP
Syncor Intl. Corp.
Microbiology · 101d
Cleared Jun 21, 1985
GIBCO MYCOTECT 189-5670
K851275 · KIW
Gibco Laboratories Life Technologies,...
Microbiology · 81d
Cleared Jun 21, 1985
VIRTRAN VIRAL TRANPORTER
K851378 · LIO
Diagnon Corp.
Microbiology · 74d
Cleared Jun 21, 1985
TIMENTIN 85 MCG. SENSI-DISC
K851622 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 64d
Cleared Jun 10, 1985
WILLCOGEN MENINGITIDIS KIT ZL25
K851691 · GTJ
Wellcome Diagnostics
Microbiology · 48d
Cleared Jun 04, 1985
BAC-T-SCREEN
K851399 · JXA
Marion Laboratories, Inc.
Microbiology · 56d
Cleared Jun 04, 1985
LYFO-KWIK OMI KIT
K851978 · JSS
Micro-Bio-Logics
Microbiology · 28d
Cleared Jun 04, 1985
DRI-FORM PSEUDOMONAS AGAR F
K852064 · JSH
Gibco Laboratories Life Technologies,...
Microbiology · 22d
Cleared Jun 04, 1985
IDS RAPID E PLUS SYSTEM
K852110 · JSS
Innovative Diagnostic Systems, Inc.
Microbiology · 20d
Cleared May 29, 1985
BACTIGEN GROUP B STREPTOCOCCUS TEST
K850772 · GTZ
Armkel, LLC
Microbiology · 93d
Cleared May 29, 1985
CHAMBER V-9 PLUS AGAR
K851238 · JSJ
Bug City Company, Inc.
Microbiology · 63d
Cleared May 22, 1985
STAPHAUREX ZL30
K851949 · GTN
Wellcome Diagnostics
Microbiology · 19d
Cleared May 21, 1985
BIOGRAM
K843725 · JTN
Giles Scientific, Inc.
Microbiology · 239d
Cleared May 21, 1985
VIROGEN RUBELLA MICROTITER TEST
K844436 · LQN
Armkel, LLC
Microbiology · 186d
Cleared May 20, 1985
VIROGEN RUBELLA SLIDE TEST
K844435 · LQN
Armkel, LLC
Microbiology · 185d