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
3601–3624 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Dec 26, 1990
CAPTIA(R) SYPHILIS M, MODIFICATION
K904524 · LIP
Mercia Diagnostics , Ltd.
Microbiology · 90d
Cleared Dec 21, 1990
INDX DIP S TICKS
K901597 · LSQ
Intercare Diagnostics, Inc.
Microbiology · 260d
Cleared Dec 21, 1990
ORTHO CHLAMYDIA ANTIGEN ELISA/ELISA CULT EXTRA BUF
K903132 · LJC
Ortho Diagnostic Systems, Inc.
Microbiology · 157d
Cleared Dec 21, 1990
SEROFAST
K903958 · GSA
Intl. Mycoplasma/Mdc Assoc.
Microbiology · 115d
Cleared Dec 21, 1990
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL/MODIFIED
K904523 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 86d
Cleared Dec 18, 1990
TOXO-CUBE
K903968 · LGD
Difco Laboratories, Inc.
Microbiology · 112d
Cleared Dec 17, 1990
CMV IGM ELISA TEST
K903807 · LFZ
Gull Laboratories, Inc.
Microbiology · 119d
Cleared Dec 17, 1990
ORTHO CMV-M ANTIBODY ELISA TEST
K905077 · LFZ
Ortho Diagnostic Systems, Inc.
Microbiology · 34d
Cleared Dec 17, 1990
ORTHO CMV-G ANTIBODY ELISA TEST
K905078 · LFZ
Ortho Diagnostic Systems, Inc.
Microbiology · 34d
Cleared Dec 17, 1990
SAF FIXATIVE
K905120 · LIO
Gibson Laboratories, Inc.
Microbiology · 33d
Cleared Dec 14, 1990
3M IGG FASTLYME(TM) TEST
K895713 · LSR
3M Company
Microbiology · 445d
Cleared Dec 13, 1990
QUALTURE
K903470 · JXA
Future Medical Technologies Intl., Inc.
Microbiology · 134d
Cleared Dec 13, 1990
PATHODX HERPES TYPING
K904167 · GQL
Diagnostic Products Corp.
Microbiology · 93d
Cleared Dec 04, 1990
TRANSTAT-CMV(TM)
K903308 · LFX
Ab Sangtec Medical
Microbiology · 133d
Cleared Dec 04, 1990
VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG
K903882 · GQW
Viral Antigens, Inc.
Microbiology · 104d
Cleared Dec 04, 1990
RUBELLA IGM ELISA TEST
K904084 · LFX
Gull Laboratories, Inc.
Microbiology · 90d
Cleared Dec 04, 1990
P AND T MEDIUM
K904773 · JTW
Gibson Laboratories, Inc.
Microbiology · 43d
Cleared Dec 04, 1990
RUBEOLA IGG ELISA TEST
K904854 · LJB
Gull Laboratories, Inc.
Microbiology · 36d
Cleared Dec 04, 1990
ORTHO RUBELLA-M ANTIBODY ELISA TEST
K905079 · LFX
Ortho Diagnostic Systems, Inc.
Microbiology · 21d
Cleared Nov 13, 1990
EF SYNERGY QUAD
K903589 · JWY
Remel Co.
Microbiology · 97d
Cleared Nov 13, 1990
ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM.
K904268 · MDK
Gen-Probe, Inc.
Microbiology · 56d
Cleared Nov 13, 1990
ACCUPROBE MYCOBACTERIUM KANSASII CULT CONFIRM TEST
K904463 · LQF
Gen-Probe, Inc.
Microbiology · 43d
Cleared Nov 08, 1990
FASTIDIOUS MIC PANEL
K901598 · JWY
Microtech Medical Systems, Inc.
Microbiology · 217d
Cleared Oct 16, 1990
TOXO IGM ELISA TEST
K903324 · LGD
Gull Laboratories, Inc.
Microbiology · 83d