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
2593–2616 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Oct 25, 1996
MEROPENEM, 10 MCG, SENSI-DISC
K963845 · JTN
Becton Dickinson Microbiology Systems
Microbiology · 30d
Cleared Oct 24, 1996
INCSTAR RUBELLA IGG FAST ELISA ASSAY
K960358 · LFX
Incstar Corp.
Microbiology · 273d
Cleared Oct 24, 1996
INCSTAR RUBELLA IGG ELISA ASSAY
K960367 · LFX
Incstar Corp.
Microbiology · 273d
Cleared Oct 24, 1996
ETEST FOR CEFEPIME
K963107 · JWY
Ab Biodisk
Microbiology · 73d
Cleared Oct 18, 1996
TRUST
K954994 · GMQ
Guardian Scientific, Corp.
Microbiology · 353d
Cleared Oct 17, 1996
INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530
K960434 · LFZ
Incstar Corp.
Microbiology · 260d
Cleared Oct 15, 1996
HAEMOPHILUS TEST MEDIUM AGAR (HTM)
K962744 · JSO
Prepared Media Laboratory, Inc.
Microbiology · 92d
Cleared Oct 11, 1996
OSOM STREP A TEST
K961423 · GTZ
Wyntek Diagnostics, Inc.
Microbiology · 182d
Cleared Oct 09, 1996
OPUS CMV TEST SYSTEM-MODIFICATION
K963084 · LFZ
Behring Diagnostics, Inc.
Microbiology · 62d
Cleared Oct 08, 1996
ETEST SUBMISSION FOR AMOXICILLIN
K960991 · JWY
Ab Biodisk
Microbiology · 211d
Cleared Oct 08, 1996
IDS RAPID CB PLUS SYSTEM
K962966 · JTO
Innovative Diagnostic Systems, Inc.
Microbiology · 70d
Cleared Oct 07, 1996
VIDAS CHLAMYDIA BLOCKING ASSAY
K955627 · LJC
Biomerieux Vitek, Inc.
Microbiology · 301d
Cleared Oct 07, 1996
EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT
K962146 · GTZ
Excel Scientific, Inc.
Microbiology · 126d
Cleared Oct 07, 1996
MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOOD
K963036 · JTZ
Becton Dickinson Microbiology Systems
Microbiology · 63d
Cleared Oct 02, 1996
ENTERIC PATHOGEN TRANSPORT (EPT) (E1020,E1000)
K962745 · JSN
Prepared Media Laboratory, Inc.
Microbiology · 79d
Cleared Sep 30, 1996
SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
K962867 · JWY
Sensititre Alamar
Microbiology · 69d
Cleared Sep 26, 1996
DISPENS-O-DISC MEROPENEM
K963508 · JTN
Difco Laboratories, Inc.
Microbiology · 23d
Cleared Sep 24, 1996
AXSYM RUBELLA IGG ANTIBODY ASSAY
K954045 · LFX
Abbott Laboratories
Microbiology · 392d
Cleared Sep 20, 1996
AXSYM CMV IGG ANTIBODY ASSAY
K953943 · LFZ
Abbott Laboratories
Microbiology · 396d
Cleared Sep 18, 1996
GONOPOX TEST KIT
K960759 · JSX
Medtex Laboratories, Inc.
Microbiology · 205d
Cleared Sep 18, 1996
10B ARGININE BROTH
K961046 · JSM
Remel, L.P.
Microbiology · 187d
Cleared Sep 18, 1996
MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM
K962843 · JSM
Starplex Scientific, Inc.
Microbiology · 58d
Cleared Sep 17, 1996
MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT
K952220 · LYR
Meretek Diagnostics, Inc.
Microbiology · 495d
Cleared Sep 13, 1996
CLEARVIEW C. DIFF A
K955067 · MCB
Unipath , Ltd.
Microbiology · 312d