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
4033–4056 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Aug 29, 1988
SCEPTOR - NEW ANTIMICROBIAL AGENT: RIFAMPIN
K882909 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 48d
Cleared Aug 25, 1988
HYBRIWICK SYSTEM: HERPES DNA PROBE TEST KIT
K873529 · GQN
Diagnostic Hybrids, Inc.
Microbiology · 359d
Cleared Aug 25, 1988
XACT NEISSERIA
K880511 · JSX
Austin Biological Laboratories
Microbiology · 198d
Cleared Aug 25, 1988
HISTO-CHECK SLIDES
K883208 · LJG
Val Tech Diagnostics, Inc.
Microbiology · 27d
Cleared Aug 25, 1988
RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT
K883333 · JTL
Immuno-Mycologics, Inc.
Microbiology · 16d
Cleared Aug 17, 1988
SCEPTOR NEW ANTIMICROBIAL AGENT: AMPICILLIN/SULBAC
K882910 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 36d
Cleared Aug 17, 1988
SCEPTOR EXTEN. OF CONCENTRATION RANGE: PENCILLIN
K882911 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 36d
Cleared Aug 17, 1988
SCEPTOR NEW ANTIMICROBIAL AGENT: IMIPENEM
K882912 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 36d
Cleared Aug 15, 1988
FASTIDIOUS INOCULUM BROTH
K883075 · JSD
Baxter Healthcare Corp
Microbiology · 33d
Cleared Aug 12, 1988
SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT
K874544 · LGO
Molecular Biosystems, Inc.
Microbiology · 283d
Cleared Aug 12, 1988
IDS RAPID ANA SYSTEM
K882960 · JSP
Innovative Diagnostic Systems, Inc.
Microbiology · 29d
Cleared Aug 04, 1988
CAPTIA(R) SYPHILIS-G
K881425 · LIP
Mercia Diagnostics , Ltd.
Microbiology · 121d
Cleared Aug 04, 1988
MERIFLUOR(TM) PNEUMOCYSTIS
K881608 · LYF
Meridian Diagnostics, Inc.
Microbiology · 114d
Cleared Aug 03, 1988
WELLCOZYME HSV WZO2
K875311 · GQN
Wellcome Diagnostics
Microbiology · 218d
Cleared Aug 03, 1988
COLORGENE HSV DNA HYBRIDIZATION TEST
K880604 · GQN
Enzo Biochem, Inc.
Microbiology · 173d
Cleared Aug 03, 1988
FIAX TEST KIT FOR EB-VCA-G ANTIBODY
K882023 · LSE
Whittaker Bioproducts, Inc.
Microbiology · 78d
Cleared Aug 03, 1988
FITC MURINE MONOCLONAL ANTI-CMV IGG
K882024 · GQH
Whittaker Bioproducts, Inc.
Microbiology · 78d
Cleared Aug 01, 1988
CAPTIA TOXO-G
K880918 · LGD
Mercia Diagnostics , Ltd.
Microbiology · 150d
Cleared Aug 01, 1988
ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT
K881932 · GQH
Ortho Diagnostic Systems, Inc.
Microbiology · 83d
Cleared Jul 25, 1988
ABBOTT TESTPACK CHLAMYDIA
K880783 · LJC
Abbott Laboratories
Microbiology · 150d
Cleared Jul 18, 1988
SCEPTOR GRAM-NEGATIVE URINE ISOLATE MIC/ID PANEL
K882299 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 46d
Cleared Jul 18, 1988
SOC SLIDE CULTURE SYSTEM
K882371 · JXC
The Cancer Center AT Wadley Institutes
Microbiology · 40d
Cleared Jul 18, 1988
DIVERSI-KIT
K882485 · LIO
Intl. Cancer Screening Laboratories,...
Microbiology · 32d
Cleared Jul 14, 1988
SCEPTOR - NEW ANTIMICROBIAL AGENT: CEFACLOR
K881716 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 84d