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
6841–6864 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Aug 22, 1979
LEVINE EMB AGAR
K791519 · JSI
Isle Media and Sterile Products, Inc.
Microbiology · 14d
Cleared Aug 22, 1979
EMB AGAR (EOSIN METHYLENE BLUE AGAR)
K791520 · JSI
Isle Media and Sterile Products, Inc.
Microbiology · 14d
Cleared Aug 16, 1979
ANTISERUM TO HUMAN FC
K790715 · DAS
Kent Laboratories, Inc.
Microbiology · 126d
Cleared Aug 16, 1979
RUBAZYME
K790976 · GOL
Abbott Laboratories
Microbiology · 85d
Cleared Aug 16, 1979
COCCIDIODES (COCCI)
K791381 · GMG
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Aug 16, 1979
CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION
K791382 · GMD
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Aug 16, 1979
CANDIDA IMMUNODIFFUSION KIT #CA1001
K791383 · GMI
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Aug 16, 1979
FUNGAL IMMUNODIFFUSION KIT #ID1001
K791384 · GMJ
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Aug 16, 1979
NEGATIVE CONTROL SERUM FOR CF RO ID
K791385 · GSN
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Aug 16, 1979
ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM
K791386 · KFG
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Aug 16, 1979
ASPERGILLUS MYCELIAL ANTIGEN #CF10024X
K791387 · JWT
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Aug 16, 1979
ANTI-COCCIDIOIDES SERUM #CF10028X
K791388 · GMH
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Aug 16, 1979
COCCIDIOIDES ANTIGEN #CF10023X
K791389 · GMI
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Aug 16, 1979
ANTI-BLASTOMYCES SERUM #CF10027X
K791390 · GMK
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Aug 16, 1979
ANTI-HISTOPLASMA SERUM #CF10026X
K791392 · GMK
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Aug 16, 1979
HISTOPLASMA YEAST ANTI #CF10021X
K791393 · GMJ
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Aug 16, 1979
HISTOPLASMA MYCELIAL #CF10020X
K791394 · GMJ
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Aug 16, 1979
ANTI-HISTOPLASMA SERUM #CF10025X
K791395 · GMK
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Jul 24, 1979
ANTI-DNASE B REAGENT SYSTEM
K790997 · GTR
Calbiochem-Behring Corp.
Microbiology · 56d
Cleared Jul 17, 1979
TRYPTIC SOY BROTH
K791171 · JSC
Isle Media and Sterile Products, Inc.
Microbiology · 22d
Cleared Jul 17, 1979
NUTRIENT BROTH
K791193 · JSC
Isle Media and Sterile Products, Inc.
Microbiology · 22d
Cleared Jul 17, 1979
BRAIN HEART INFUSION BROTH
K791194 · JSC
Isle Media and Sterile Products, Inc.
Microbiology · 22d
Cleared Jul 17, 1979
BRAIN HEART INFUSION WITH BROTH
K791291 · JSC
Isle Media and Sterile Products, Inc.
Microbiology · 22d
Cleared Jul 17, 1979
BRAIN HEART INFUSION WITH AGAR BROTH
K791292 · JSC
Isle Media and Sterile Products, Inc.
Microbiology · 22d