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
3913–3936 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Mar 21, 1989
CARY-BLAIR TRANSPORT SYSTEM
K885245 · JSM
Precision Biologicals, Inc.
Microbiology · 89d
Cleared Mar 21, 1989
PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT
K890768 · LYF
Genetic Systems Corp.
Microbiology · 34d
Cleared Mar 16, 1989
CRYPTOSPORIDIUM CONTROL SLIDE
K890670 · LJG
Scientific Device Laboratory, Inc.
Microbiology · 35d
Cleared Mar 16, 1989
GRAM STAIN CONTROL SLIDE
K890718 · LJG
Scientific Device Laboratory, Inc.
Microbiology · 31d
Cleared Mar 15, 1989
LYME DISEASE IFA (IGM)
K883767 · LSR
Hillcrest Biologicals
Microbiology · 190d
Cleared Mar 15, 1989
VISUWELL REAGIN TEST 960 TEST KIT
K885298 · GMP
Allelix Diagnostics, Inc.
Microbiology · 78d
Cleared Mar 15, 1989
HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES
K890281 · LSR
Cambridge Bioscience Corp.
Microbiology · 57d
Cleared Mar 14, 1989
FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY
K884047 · LYF
Disease Detection International, Inc.
Microbiology · 169d
Cleared Mar 14, 1989
GIARDIA STOOL ANTIGEN TEST KIT
K890003 · KHW
Lmd Laboratories
Microbiology · 70d
Cleared Mar 13, 1989
RAPID DIAG. SYSTEM FOR MYCOBACTERIUM GORDONAE
K890089 · LQF
Gen-Probe, Inc.
Microbiology · 62d
Cleared Mar 10, 1989
VIRGO HSV-2 IGG ELISA
K883281 · GQO
Electro-Nucleonics, Inc.
Microbiology · 219d
Cleared Mar 10, 1989
VIRGO HSV-1 IGG ELISA
K883282 · GQO
Electro-Nucleonics, Inc.
Microbiology · 219d
Cleared Mar 10, 1989
VIRGO(R) VZV-IGG ELISA
K883427 · GQX
Electro-Nucleonics, Inc.
Microbiology · 207d
Cleared Mar 02, 1989
LYME ELISA TEST SYSTEM
K885317 · LSR
Zeus Scientific, Inc.
Microbiology · 62d
Cleared Mar 02, 1989
DENTOCULT SM-STRIP MUTANS
K890199 · JSI
Orion Corp.
Microbiology · 43d
Cleared Feb 17, 1989
PHADEBACT SHIGELLA TEST
K880752 · GNB
Pharmacia, Inc.
Microbiology · 359d
Cleared Feb 17, 1989
BION DIRECT IDENTIFICATION CONTROL SLIDE
K890616 · LJG
Bion Ent., Ltd.
Microbiology · 10d
Cleared Feb 17, 1989
JAMES REAGENT
K890625 · JTO
Dms Products, Inc.
Microbiology · 10d
Cleared Feb 16, 1989
PRO DISCS
K882630 · JTO
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 234d
Cleared Feb 16, 1989
ALN DISCS
K882636 · JTO
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 234d
Cleared Feb 16, 1989
KODAK SURECELL HERPES (HSV) TEST KIT
K884680 · LGC
Eastman Kodak Company
Microbiology · 99d
Cleared Feb 16, 1989
MURINE MONOCLONAL ANTI-ADENOVIRUS IGG
K885310 · GNY
Whittaker Bioproducts, Inc.
Microbiology · 49d
Cleared Feb 16, 1989
WELLCOLEX COLOUR SALMONELLA TEST ZL 50
K890146 · GRM
Wellcome Diagnostics
Microbiology · 34d
Cleared Feb 08, 1989
VIRGO (R) CMV-IGG ELISA
K883102 · GQI
Electro-Nucleonics, Inc.
Microbiology · 201d