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
4993–5016 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Sep 26, 1985
MEASLES VIRUS RUBEOLA
K843662 · GRJ
Institute Virion , Ltd.
Microbiology · 374d
Cleared Sep 26, 1985
PARAINFLUENZA 1
K843665 · GQS
Institute Virion , Ltd.
Microbiology · 374d
Cleared Sep 26, 1985
PARAINFLUENZA 3
K843667 · GQS
Institute Virion , Ltd.
Microbiology · 374d
Cleared Sep 26, 1985
RESPIRATORY SYNCYTIAL VIRUS
K843673 · GQG
Institute Virion , Ltd.
Microbiology · 374d
Cleared Sep 26, 1985
VARICELLA/ZOSTER VIRUS
K843676 · GQW
Institute Virion , Ltd.
Microbiology · 374d
Cleared Sep 20, 1985
MIC-CONCEPT SYSTEM
K852613 · LTW
Microtech Medical Systems, Inc.
Microbiology · 93d
Cleared Sep 19, 1985
SELECTICULT-CHLAMYDIA
K852869 · LKH
Scott Laboratories, Inc.
Microbiology · 73d
Cleared Sep 19, 1985
IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPED
K853122 · GMS
Immuno-Products Industries
Microbiology · 56d
Cleared Sep 19, 1985
MIC-CONCEPT VIEWBOX
K853745 · LIB
Microtech Medical Systems, Inc.
Microbiology · 10d
Cleared Sep 17, 1985
ABBOTT RSV EIA
K852472 · LKT
Abbott Laboratories
Microbiology · 98d
Cleared Sep 17, 1985
COLUMBIZ BLOOD AGAR
K853690 · JSG
Micro Media Laboratories
Microbiology · 13d
Cleared Sep 17, 1985
TERGITOL 7 AGAR
K853691 · JSI
Micro Media Laboratories
Microbiology · 13d
Cleared Sep 16, 1985
FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM
K851450 · JIW
Flow Cytometry Standards Corp.
Microbiology · 158d
Cleared Sep 16, 1985
ENZYGNOST + ANTI-CMV IGG TEST
K852478 · LFZ
Behring Diagnostics, Inc.
Microbiology · 97d
Cleared Sep 16, 1985
CMV-IHA
K852494 · LJO
Hillcrest Biologicals
Microbiology · 96d
Cleared Sep 16, 1985
MICROTRAK CHLAMYDIA TRACHOMATIS DIR SPECIMEN TEST
K852779 · LJP
Syva Co.
Microbiology · 77d
Cleared Sep 16, 1985
PRECEPT CEFTRIAXONE
K853273 · LTW
Austin Biological Laboratories
Microbiology · 42d
Cleared Sep 16, 1985
PRECEPT CEFOPERAZONE
K853596 · LTW
Austin Biological Laboratories
Microbiology · 20d
Cleared Sep 16, 1985
APL MOTILITY INDOLE ORNITHINE AGAR
K853610 · JSH
Apl Medical Supplies
Microbiology · 18d
Cleared Sep 16, 1985
APL SIMMONS CITRATE AGAR
K853617 · JSI
Apl Medical Supplies
Microbiology · 18d
Cleared Sep 16, 1985
APL SIM MEDIUM
K853618 · JSH
Apl Medical Supplies
Microbiology · 18d
Cleared Sep 16, 1985
APL TRIPLE SUGAR IRON AGAR
K853619 · JSH
Apl Medical Supplies
Microbiology · 18d
Cleared Sep 16, 1985
PRECEPT TM CARBENICILLIN
K853685 · LTW
Austin Biological Laboratories
Microbiology · 178d
Cleared Sep 16, 1985
PRECEPT METHICILLIN
K853772 · LTW
Austin Biological Laboratories
Microbiology · 147d