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
5329–5352 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jan 07, 1985
THIOGLYCOLLATE W/O INDICATOR
K844536 · JSG
bioMerieux, Inc.
Microbiology · 47d
Cleared Jan 07, 1985
FLUID THIOGLYCOLLATE MEDIUM W/INDICATOR
K844537 · JSG
bioMerieux, Inc.
Microbiology · 47d
Cleared Jan 07, 1985
COOKED MEAT MEDIUM
K844538 · JSG
bioMerieux, Inc.
Microbiology · 47d
Cleared Jan 07, 1985
PHENOL RED BROTH W/CARBOHYDRATES
K844539 · JSF
bioMerieux, Inc.
Microbiology · 47d
Cleared Jan 07, 1985
CYSTINE TRYPTIC AGAR W/FRUCTOSE
K844540 · JSF
bioMerieux, Inc.
Microbiology · 47d
Cleared Jan 07, 1985
TRYPTIC SOY BROTH
K844541 · JSG
bioMerieux, Inc.
Microbiology · 47d
Cleared Jan 05, 1985
YERSINIA SELECTIVE AGAR
K844535 · JSI
bioMerieux, Inc.
Microbiology · 45d
Cleared Jan 04, 1985
DIRECTIGEN GROUP A STREP TEST KIT
K843713 · GTZ
Bd Becton Dickinson Vacutainer...
Microbiology · 105d
Cleared Jan 04, 1985
LATEX-R RICKETTSII
K843794 · GPP
Health Research, Inc.
Microbiology · 99d
Cleared Jan 04, 1985
BBL PORT-A-CUL 21628 DOUBLE SWAB SULTURE COLLECTIO
K844369 · JSM
Precision Dynamics Corp.
Microbiology · 52d
Cleared Jan 04, 1985
BBL PORT-A-CUL 21627 SINGLE SWAB CULTURE COLLECT
K844370 · JSM
Precision Dynamics Corp.
Microbiology · 52d
Cleared Jan 04, 1985
BILE DIFFERENTIAL DISK
K844380 · JTO
Anaerobe Systems
Microbiology · 52d
Cleared Jan 04, 1985
COLISTIN 10 MCG. DIFFERENTIAL DISK
K844381 · JTO
Anaerobe Systems
Microbiology · 52d
Cleared Jan 04, 1985
VANCOMYCIN 5MCG DIFFERENTIAL DISK
K844382 · JTO
Anaerobe Systems
Microbiology · 52d
Cleared Jan 04, 1985
KANAMYCIN 1000 MCG DIFFERENTIAL DISK
K844383 · JTO
Anaerobe Systems
Microbiology · 52d
Cleared Jan 04, 1985
HAND-HELD SLIDE READER
K844473 · LIB
Portable Medical Laboratories, Inc.
Microbiology · 46d
Cleared Jan 04, 1985
VIRAL TRANSPORT MEDIA
K844747 · JSM
Hillcrest Biologicals
Microbiology · 29d
Cleared Dec 27, 1984
EBNA ACIF KIT
K840417 · LLM
Litton Bionetics
Microbiology · 331d
Cleared Dec 24, 1984
MIC-BIO-PLATE
K844903 · JWY
Pasco Laboratories, Inc.
Microbiology · 10d
Cleared Dec 14, 1984
API UNISCEPT MIC 100UL
K844159 · LTW
Analytical Products, Inc.
Microbiology · 51d
Cleared Dec 13, 1984
PYRIDOXAL DISC
K844020 · JTO
Remel Co.
Microbiology · 59d
Cleared Dec 13, 1984
E-COLI-CHEK TUBE
K844276 · JTO
E-Y Laboratories, Inc.
Microbiology · 38d
Cleared Dec 12, 1984
AMS ANA CARD
K843686 · JSP
Vitek Systems, Inc.
Microbiology · 85d
Cleared Dec 06, 1984
ENTAMOEBA HISTOLYTICA HK-9 ANTIGEN (AXENIC)
K844141 · KHW
Lmd Laboratories
Microbiology · 44d