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
3337–3360 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jul 28, 1992
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K922168 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 81d
Cleared Jul 28, 1992
LORACARBEF 30MCG DISK
K922791 · JTN
Difco Laboratories, Inc.
Microbiology · 49d
Cleared Jul 28, 1992
CEFZIL
K922793 · JTN
Difco Laboratories, Inc.
Microbiology · 49d
Cleared Jul 28, 1992
ENOXACIN
K922794 · JTN
Difco Laboratories, Inc.
Microbiology · 49d
Cleared Jul 27, 1992
HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS
K920222 · LJO
Akers Research Corp.
Microbiology · 193d
Cleared Jul 27, 1992
PHARMACIA CMV IGM ELISA
K921011 · LFZ
Pharmacia Diagnostics, Inc.
Microbiology · 146d
Cleared Jul 23, 1992
ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE
K921435 · LQF
Gen-Probe, Inc.
Microbiology · 120d
Cleared Jul 22, 1992
ABBOTT STREP A CONTROLS
K922490 · GTY
Abbott Laboratories
Microbiology · 56d
Cleared Jul 16, 1992
TESTPACK PLUS STREP A
K922345 · GTZ
Abbott Laboratories
Microbiology · 58d
Cleared Jul 14, 1992
AMRAD HEL-PTEST
K920827 · LYR
Amrad
Microbiology · 141d
Cleared Jul 14, 1992
ESP BLOOD CULTURE SYSTEM
K921637 · MDB
Difco Laboratories, Inc.
Microbiology · 99d
Cleared Jul 10, 1992
PREMIER COCCIDIOIDES
K915493 · MIY
Meridian Diagnostics, Inc.
Microbiology · 214d
Cleared Jul 08, 1992
TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO
K920702 · LGD
Pharmacia Diagnostics, Inc.
Microbiology · 141d
Cleared Jul 01, 1992
SENSITITRE ARIS MODULE
K911419 · LRG
Sensititre , Ltd.
Microbiology · 457d
Cleared Jul 01, 1992
BACTEC 9120 SYSTEM
K922475 · MDB
Bd Becton Dickinson Vacutainer...
Microbiology · 36d
Cleared Jun 29, 1992
MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM
K921556 · LJZ
Medical Diagnostic Technologies, Inc.
Microbiology · 89d
Cleared Jun 29, 1992
COXSACKIE VIRUS B1-B6 CF ANTIGENS
K921618 · GNG
Virion (U.S.), Inc.
Microbiology · 84d
Cleared Jun 22, 1992
MODIFIED ORTHO EBV VCA-IGG ELISA
K920412 · MCD
Ortho Diagnostic Systems, Inc.
Microbiology · 143d
Cleared Jun 19, 1992
URINE CULTUR STABILIZATION TRANSPORT TUBE
K920761 · LIO
Bio Medicus, Inc.
Microbiology · 121d
Cleared Jun 19, 1992
BACTIDROP INDOLE (ERLICH'S)
K920973 · JTO
Remel Co.
Microbiology · 109d
Cleared Jun 19, 1992
BACTIDROP ACRIDINE ORANGE
K920974 · JFO
Remel Co.
Microbiology · 109d
Cleared Jun 19, 1992
DRYSLIDE(TM), PYR
K921583 · JTO
Difco Laboratories, Inc.
Microbiology · 102d
Cleared Jun 19, 1992
PROSPECT(TM) GIARDIA MICROTITER ASSAY/MODIFICATION
K922010 · MHI
Alexon, Inc.
Microbiology · 50d
Cleared Jun 09, 1992
SEROELISA(TM) CHLAMYDIA IGA TEST KIT
K914327 · LJC
Savyon Diagnostics , Ltd.
Microbiology · 256d