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
2545–2568 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Mar 03, 1997
KENLOR H. PYLORI CONTROL SERUM
K964014 · LYR
Kenlor Industries, Inc.
Microbiology · 147d
Cleared Feb 24, 1997
CHLAMYDIA IGG ELISA TEST SYSTEM
K962558 · LJC
Armkel, LLC
Microbiology · 238d
Cleared Feb 20, 1997
HEMAGEN CMV IGG KIT
K944438 · LFZ
Hemagen Diagnostics, Inc.
Microbiology · 892d
Cleared Feb 20, 1997
ACCUMETER H. PYLORI TEST
K965099 · LYR
Chemtrak, Inc.
Microbiology · 62d
Cleared Feb 07, 1997
REMEL STAPH LATEX KIT
K964315 · JWX
Remel, L.P.
Microbiology · 101d
Cleared Feb 07, 1997
IMIPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964487 · JTN
Unipath , Ltd.
Microbiology · 92d
Cleared Feb 07, 1997
CEFACLOR ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964489 · JTN
Unipath , Ltd.
Microbiology · 91d
Cleared Feb 07, 1997
AZTREONAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964490 · JTN
Unipath , Ltd.
Microbiology · 91d
Cleared Feb 07, 1997
NORFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964491 · JTN
Unipath , Ltd.
Microbiology · 92d
Cleared Feb 07, 1997
CIPROFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964492 · JTN
Unipath , Ltd.
Microbiology · 91d
Cleared Feb 07, 1997
CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964495 · JTN
Unipath , Ltd.
Microbiology · 91d
Cleared Feb 06, 1997
OFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964493 · JTN
Unipath , Ltd.
Microbiology · 90d
Cleared Feb 06, 1997
CEFIXIME ANTIMICROBIAL SUSCEPTIBILTY TEST DISC
K964496 · JTN
Unipath , Ltd.
Microbiology · 90d
Cleared Feb 06, 1997
SULBACTAM/AMPICILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964501 · JTN
Unipath , Ltd.
Microbiology · 90d
Cleared Feb 06, 1997
CEFTIZOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964512 · JTN
Unipath , Ltd.
Microbiology · 90d
Cleared Feb 06, 1997
LYFO(TM) DIFFERENTIAL DISK-BACITRACIN
K970009 · JTO
Microbiologics, Inc.
Microbiology · 35d
Cleared Feb 04, 1997
ACCESS CHLAMYDIA ASSAY
K960850 · LJC
Bio-Rad Laboratories, Inc.
Microbiology · 340d
Cleared Feb 04, 1997
RAPID GRAM-POSITIVE ID SYSTEM
K961730 · LQL
Becton Dickinson Microbiology Systems
Microbiology · 277d
Cleared Feb 04, 1997
BBLCRYSTAL GRAM-POSITIVE ID SYSTEM
K961968 · LQL
Bd Becton Dickinson Vacutainer...
Microbiology · 260d
Cleared Feb 04, 1997
HERPES GROUP IGG ELISA TEST SYSTEM
K963645 · LGC
Armkel, LLC
Microbiology · 145d
Cleared Feb 04, 1997
PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY
K964864 · LLH
Alexon Biomedical, Inc.
Microbiology · 62d
Cleared Feb 04, 1997
MINK LUNG CELL CULTURE
K965047 · KIR
Neogenex
Microbiology · 48d
Cleared Jan 27, 1997
H.PYLORI CONTROLS
K964675 · LYR
Pyramid Biological Corp.
Microbiology · 67d
Cleared Jan 22, 1997
SERAQUEST HSV IGG
K963282 · LGC
Quest Intl., Inc.
Microbiology · 154d