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
2473–2496 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Aug 20, 1997
IMMUNOCARD STAT! ROTAVIRUS
K971585 · LIQ
Meridian Diagnostics, Inc.
Microbiology · 111d
Cleared Aug 20, 1997
CLARITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971638 · JTN
Oxoid , Ltd.
Microbiology · 110d
Cleared Aug 20, 1997
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL
K972448 · JSL
Copan Italia Spa
Microbiology · 51d
Cleared Aug 20, 1997
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL
K972449 · JSL
Copan Italia Spa
Microbiology · 51d
Cleared Aug 20, 1997
PASCO MIC AND MIC/ID PANELS
K972567 · JWY
Pasco Laboratories, Inc.
Microbiology · 50d
Cleared Aug 15, 1997
PASCO MIC AND MIC/ID PANELS
K971951 · JWY
Pasco Laboratories, Inc.
Microbiology · 79d
Cleared Aug 13, 1997
TICARCILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971632 · JTN
Oxoid , Ltd.
Microbiology · 103d
Cleared Aug 13, 1997
ABBOTT STREP A CONTROLS
K972182 · MJZ
Abbott Diagnostics
Microbiology · 76d
Cleared Aug 12, 1997
ACCURUN 121 HAV IGM POSITIVE CONTROL
K971657 · JJY
Boston Biomedica, Inc.
Microbiology · 98d
Cleared Aug 12, 1997
ACCURUN 117 HBEAG POSITIVE CONTROL
K972048 · JJY
Boston Biomedica, Inc.
Microbiology · 71d
Cleared Aug 12, 1997
CHLAMYDIATROL AG
K972129 · MJZ
Blackhawk Biosystems, Inc.
Microbiology · 67d
Cleared Aug 08, 1997
ROTAVIRUS EIA
K964424 · LIQ
Trinity Biotech, Inc.
Microbiology · 276d
Cleared Aug 08, 1997
BACTEC MYCO/F-SPUTA CULTURE VIALS
K972758 · MDB
Becton Dickinson Microbiology Systems
Microbiology · 53d
Cleared Aug 07, 1997
ACCURUN 120 HAV IGG POSITIVE CONTROL
K971406 · JJY
Boston Biomedica, Inc.
Microbiology · 113d
Cleared Aug 07, 1997
ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL
K972307 · JJY
Boston Biomedica, Inc.
Microbiology · 49d
Cleared Aug 01, 1997
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
K972180 · JWY
Dade Microscan, Inc.
Microbiology · 52d
Cleared Aug 01, 1997
MODIFICATION OF EST CULTURE SYSTEM II - MYCO
K972756 · MDB
Accumed Intl., Inc.
Microbiology · 63d
Cleared Jul 28, 1997
FOSFOMYCIN, 200 MG, SENSI-DISC
K972098 · JTN
Becton Dickinson Microbiology Systems
Microbiology · 54d
Cleared Jul 23, 1997
STREP A OIA MAX
K962060 · GTZ
Biostar, Inc.
Microbiology · 421d
Cleared Jul 22, 1997
TOX A/B TEST
K971182 · LLH
Techlab, Inc.
Microbiology · 113d
Cleared Jul 22, 1997
QUANTA LITE RUBEOLA (MEASLES) IGG
K971620 · LJB
Inova Diagnostics, Inc.
Microbiology · 82d
Cleared Jul 14, 1997
MYCOPLASMA IGG ELISA TEST SYSTEM
K971393 · LJZ
Immunoprobe, Inc.
Microbiology · 96d
Cleared Jul 14, 1997
ETEST FOR LEVOFLOXACIN
K971697 · JWY
Ab Biodisk
Microbiology · 67d
Cleared Jul 08, 1997
QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS
K972146 · LYR
Consolidated Technologies, Inc.
Microbiology · 29d