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
6673–6696 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Feb 13, 1980
CULTURIA MACCONKEY/CLED #DM87
K800215 · JXA
Clinical Convenience Products, Inc.
Microbiology · 9d
Cleared Feb 13, 1980
SEROCLUSTER U AND V
K800240 · JTC
Corning Costar Corp.
Microbiology · 8d
Cleared Jan 28, 1980
CAMPY BLOOD AGAR
K792674 · JSJ
Regional Media Laboratories
Microbiology · 32d
Cleared Jan 24, 1980
CAMPY THIO
K792676 · JSJ
Remel Co.
Microbiology · 28d
Cleared Jan 24, 1980
NEGATIVE CONTROL SERUM
K792694 · GMK
Meridian Diagnostics, Inc.
Microbiology · 28d
Cleared Jan 24, 1980
CANDIDA ALBICANS, ANTIGEN
K792716 · GMI
Meridian Diagnostics, Inc.
Microbiology · 28d
Cleared Jan 23, 1980
FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD
K792249 · GOL
Intl. Diagnostic Technology
Microbiology · 77d
Cleared Jan 23, 1980
BLASTOMYCES/ANTIGEN FOR IMMUNODIFUSION
K792683 · JWW
Meridian Diagnostics, Inc.
Microbiology · 27d
Cleared Jan 23, 1980
HISTOPLASMA CAPSULATUM, ANTIGEN
K792701 · GMJ
Meridian Diagnostics, Inc.
Microbiology · 27d
Cleared Jan 23, 1980
CANDIDA ALBICANS, ANTISERUM
K792713 · GMI
Meridian Diagnostics, Inc.
Microbiology · 27d
Cleared Jan 23, 1980
TRYPTIC SOY SXT AGAR W/SHEEP BLOOD
K792720 · JSJ
Gibco Laboratories Life Technologies,...
Microbiology · 23d
Cleared Jan 21, 1980
CRYPTOCOCCUS NEOFORMANS ANTISERUM, LATEX
K792693 · GMD
Meridian Diagnostics, Inc.
Microbiology · 25d
Cleared Jan 17, 1980
HISTOPLASMA CAPSULATUM, ANTISERUM
K792679 · GMK
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
BLASTOMYCES DERMATITIDIS, ANTIGEN
K792680 · JWW
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
BLASTOMYCES DERMATITIDIS POS/CONTROL
K792681 · KFH
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
COCCIDIOIDES IMMITIS, ANTIGEN
K792682 · GMI
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
COCCIDIOIDES IMMITIS, ANTISERUM,
K792684 · GMH
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
BLASTOMYCES DERMATITIDIS, ANTISERUM
K792685 · KFH
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
ASPERGILLUS SP, ANTISERUM POSITIVE
K792686 · KFG
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
ASPERGILLUS SP., ANTIGEN
K792687 · JWI
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
COCCIDIOIDES IMMITIS, ANTISERUM
K792688 · GMH
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
COCCIDIOIDES IMMITIS, ANTIGEN
K792689 · GMI
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
COCCIDIOIDES IMMITIS, LATEX AGGLUTI
K792690 · GMG
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
CRYPTOCOCCUS NEOFORMANS, ANTIGEN,
K792691 · JWK
Meridian Diagnostics, Inc.
Microbiology · 21d