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
6721–6744 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Dec 27, 1979
LYSINE IRON AGAR
K792544 · JSH
Isle Media and Sterile Products, Inc.
Microbiology · 17d
Cleared Dec 27, 1979
BACTEC BACTERIAL DETECTION SYSTEM
K792575 · JTA
Bd Becton Dickinson Vacutainer...
Microbiology · 14d
Cleared Dec 19, 1979
AMS YEAST BIOCHEMICAL CARD
K792231 · JXB
Vitek Systems, Inc.
Microbiology · 44d
Cleared Dec 19, 1979
BRAIN HEART INFUSION W/PABA, O.1%,
K792276 · JSG
Bd Becton Dickinson Vacutainer...
Microbiology · 36d
Cleared Dec 19, 1979
CULTURIA EMB/COLUMBIA CNA W/5% SHEEP
K792284 · JXA
Clinical Convenience Products, Inc.
Microbiology · 36d
Cleared Dec 19, 1979
MR-VP MEDIUM
K792286 · JSH
Isle Media and Sterile Products, Inc.
Microbiology · 36d
Cleared Dec 19, 1979
KF STREPTOCOCCUS AGAR
K792287 · JSJ
Isle Media and Sterile Products, Inc.
Microbiology · 36d
Cleared Dec 19, 1979
TRYPTONE BROTH (TRYPTOPHANE BROTH)
K792288 · JSH
Isle Media and Sterile Products, Inc.
Microbiology · 36d
Cleared Dec 07, 1979
COAGULASE PLASMA
K792235 · JTL
Remel Co.
Microbiology · 31d
Cleared Nov 30, 1979
STREP CULTURETTE
K792201 · JSN
Marion Health & Safety, Inc.
Microbiology · 28d
Cleared Nov 16, 1979
ROTAZYME
K791746 · LFX
Abbott Laboratories
Microbiology · 67d
Cleared Nov 16, 1979
3M MICROBIAL PROFILE SYSTEM GRAM
K791789 · JSS
3M Company
Microbiology · 63d
Cleared Nov 16, 1979
FIAX TEST KIT FOR ANTI-CYTOMEGALORIRUS
K791948 · GQH
Intl. Diagnostic Technology
Microbiology · 46d
Cleared Nov 16, 1979
FISHER DIAGNOSTICS ANAEROBIC BLOOD CULT
K792056 · JSC
Fisher Scientific Co., LLC
Microbiology · 32d
Cleared Nov 13, 1979
RUBELLA BIO-BEAD SCREEN KIT
K791610 · GOL
Litton Bionetics
Microbiology · 84d
Cleared Nov 13, 1979
TOXO BIO-BEAD SCREEN KIT
K791611 · GLZ
Litton Bionetics
Microbiology · 84d
Cleared Nov 13, 1979
CMV BIO-BEAD SCREEN KIT
K791612 · GQH
Litton Bionetics
Microbiology · 84d
Cleared Nov 13, 1979
HSV BIO-BEAD SCREEN KIT
K791614 · GQN
Litton Bionetics
Microbiology · 84d
Cleared Nov 13, 1979
TORCH BIO-BEAD SCREEN KIT
K791618 · GLZ
Litton Bionetics
Microbiology · 85d
Cleared Nov 13, 1979
BACTO-HATTS
K791897 · GMT
Difco Laboratories, Inc.
Microbiology · 49d
Cleared Nov 13, 1979
AMS ENTEROBACTERIACEASE CARE
K791932 · JSS
Vitek Systems, Inc.
Microbiology · 47d
Cleared Nov 13, 1979
STREP-SPEC
K791991 · JSS
Micro-Media Systems, Inc.
Microbiology · 41d
Cleared Oct 30, 1979
PHENOL RED AGAR
K791939 · JSH
Isle Media and Sterile Products, Inc.
Microbiology · 29d
Cleared Oct 30, 1979
UREA AGAR
K791940 · JSI
Isle Media and Sterile Products, Inc.
Microbiology · 29d