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
6289–6312 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Oct 20, 1981
REAGENTS FOR SERODIAGNOSIS OF ASPERGILL
K812740 · JWT
Nolan Biological Laboratories, Inc.
Microbiology · 21d
Cleared Oct 20, 1981
ANAEROBIC BLOOD AGAR
K812795 · JSG
Isle Media and Sterile Products, Inc.
Microbiology · 14d
Cleared Oct 20, 1981
ANAEROBIC CNA BLOOD AGAR
K812796 · JSJ
Isle Media and Sterile Products, Inc.
Microbiology · 14d
Cleared Oct 20, 1981
SCHAEDLER AGARS
K812797 · JSG
Isle Media and Sterile Products, Inc.
Microbiology · 14d
Cleared Oct 20, 1981
MOTILITY GI MEDIUM
K812798 · JSG
Isle Media and Sterile Products, Inc.
Microbiology · 14d
Cleared Oct 19, 1981
SEPTI-CHEK BLOOD CULTURE BOTTLE ROCHE
K812729 · JSG
Hoffmann-La Roche, Inc.
Microbiology · 21d
Cleared Oct 19, 1981
SEPTI-CHECK BLOOD CULTURE SLIDE
K812731 · JSI
Hoffmann-La Roche, Inc.
Microbiology · 21d
Cleared Oct 19, 1981
SEPTI-CHEK BH1 BLOOD CULTURE BOTTLE
K812732 · JSG
Hoffmann-La Roche, Inc.
Microbiology · 21d
Cleared Oct 06, 1981
MEZLOCILLIN 75 MCG. SENSI-DISC
K812571 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 27d
Cleared Oct 06, 1981
GC DISK
K812698 · JTR
Remel Co.
Microbiology · 14d
Cleared Oct 02, 1981
MINITECK ENTERIC BROTH & ENTEROBACTER
K812286 · JSS
Bd Becton Dickinson Vacutainer...
Microbiology · 50d
Cleared Oct 02, 1981
MEZLOCILLIN 75 MCG. SENSITIVITY DISCS
K812525 · JTN
Difco Laboratories, Inc.
Microbiology · 30d
Cleared Sep 29, 1981
RABBIT COAGULASE PLASMA
K812602 · JTL
Dutchland Laboratories, Inc.
Microbiology · 14d
Cleared Sep 29, 1981
AFB STAIN SET
K812668 · JTS
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 8d
Cleared Sep 23, 1981
CYTOMEGELISA TEST KIT
K812123
M.A. Bioproducts
Microbiology · 58d
Cleared Sep 23, 1981
DIAGNOSTIC KITS & KIT COMPONENTS
K812434 · LHT
Diagnostica, Inc.
Microbiology · 29d
Cleared Sep 23, 1981
PADAC
K812458 · JTO
Calbiochem-Behring Corp.
Microbiology · 23d
Cleared Sep 23, 1981
SENSI-TECT
K812581 · JTZ
Uti-Tect, Inc.
Microbiology · 13d
Cleared Sep 16, 1981
CYTOMEGALOVIRUS ANTIBODY TEST SYSTEM
K811671 · GQH
Zeus Scientific, Inc.
Microbiology · 93d
Cleared Sep 14, 1981
PHOS MICROTUBES
K812465 · JSF
Carr Microbiologicals
Microbiology · 14d
Cleared Sep 14, 1981
ONPX-INDOL MEDIUM MICROTUBES
K812466 · JSE
Carr Microbiologicals
Microbiology · 14d
Cleared Sep 14, 1981
PGUA-INDOL MICROTUBE
K812467 · JSE
Carr Microbiologicals
Microbiology · 14d
Cleared Sep 14, 1981
PYRR MICROTUBE
K812468 · JSF
Carr Microbiologicals
Microbiology · 14d
Cleared Sep 14, 1981
RAPID DECARBOXYLASE/DIHYDROLASE MICROTUB
K812469 · JSF
Carr Microbiologicals
Microbiology · 14d