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
3721–3744 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Mar 01, 1990
SPECIMEN CONTAINER
K896794 · LIO
Westmark, Sterile Packing Systems,...
Microbiology · 90d
Cleared Feb 27, 1990
CMV IGM ELISA TEST SYSTEM
K896355 · LFZ
Zeus Scientific, Inc.
Microbiology · 113d
Cleared Feb 26, 1990
VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY
K896097 · GQG
Vitek Systems, Inc.
Microbiology · 129d
Cleared Feb 16, 1990
QUIDEL GROUP B STREP TEST
K896265 · GTZ
Quidel Corp.
Microbiology · 108d
Cleared Feb 09, 1990
MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVE
K896566 · JWY
Medical Specialties, Inc.
Microbiology · 81d
Cleared Feb 09, 1990
ZEFAZONE SUSCEPTIBILITY POWDER
K900455 · LOP
The Upjohn Co.
Microbiology · 10d
Cleared Feb 05, 1990
SUPPLEMENT TO ANAEROBIC MIC PANEL
K896332 · JWY
Microtech Medical Systems, Inc.
Microbiology · 95d
Cleared Feb 05, 1990
CEFIXIME 5 MCG SUSCEPTIBILITY DISK
K900344 · JTN
Organon Teknika Corp.
Microbiology · 13d
Cleared Feb 02, 1990
VIRAL RESPIRATORY INDIRECT FLUORES. MONO. ANTIBODY
K896635 · GNW
Baxter Healthcare Corp
Microbiology · 72d
Cleared Feb 02, 1990
ROMCHECK SPECIMEN COLLECTION KIT
K900225 · LIO
Adeza Biomedical
Microbiology · 16d
Cleared Feb 01, 1990
PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1
K895839 · LJP
Diagnostic Products Corp.
Microbiology · 121d
Cleared Feb 01, 1990
ACCUPROBE HISTOPLASMA CAPSULATUM CULTURE CONF.TEST
K896859 · MBT
Gen-Probe, Inc.
Microbiology · 58d
Cleared Jan 29, 1990
PASCO MIC/ID GRAM-POSITIVE PANEL
K895215 · JWY
Difco Laboratories, Inc.
Microbiology · 164d
Cleared Jan 29, 1990
CLEARVIEW CHLAMYDIA
K895280 · LJC
Unipath , Ltd.
Microbiology · 158d
Cleared Jan 29, 1990
INPOUCH-TV POUCH
K896296 · JSN
Biomed Diagnostics, Inc.
Microbiology · 90d
Cleared Jan 29, 1990
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K896965 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 45d
Cleared Jan 22, 1990
VENTRESIGN STREP A TEST
K897083 · GTZ
Ventrex Laboratories, Inc.
Microbiology · 33d
Cleared Jan 16, 1990
FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A
K893579 · GNX
Whittaker Bioproducts, Inc.
Microbiology · 252d
Cleared Jan 16, 1990
EBV VCA ANTIBODY (IGM)
K896594 · LJN
Hillcrest Biologicals
Microbiology · 56d
Cleared Jan 11, 1990
WELLCOLEX COLOUR SHIGELLA TEST ZC51
K895461 · GNB
Wellcome Diagnostics
Microbiology · 127d
Cleared Jan 02, 1990
KODAK SURECELL CHLAMYDIA TEST KIT (ADD'L USES)
K895505 · LJC
Eastman Kodak Company
Microbiology · 113d
Cleared Jan 02, 1990
CEFMATZOLE 30 MCG SENSI DISC
K895679 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 104d
Cleared Jan 02, 1990
AUTOSCEPTOR
K896447 · LRG
Bd Becton Dickinson Vacutainer...
Microbiology · 54d
Cleared Dec 29, 1989
ORTHO* RUBELLA-G ANTIBODY ELISA TEST
K896479 · LFX
Ortho Diagnostic Systems, Inc.
Microbiology · 46d