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
2977–3000 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jun 07, 1995
INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) IGG ELISA KIT
K946159 · LSE
Incstar Corp.
Microbiology · 181d
Cleared Jun 01, 1995
STAPHAUREX PLUS(TM)
K945538 · JWX
Murex Diagnostics Limitd
Microbiology · 199d
Cleared May 19, 1995
HEMAGEN CHAGAS' KIT (EIA METHOD)
K930272 · MIU
Hemagen Diagnostics, Inc.
Microbiology · 850d
Cleared May 19, 1995
ACCESS(R) CHLAMYDIA EIA AND BLOCKING ASSAY
K935807 · LJC
Bio-Rad Laboratories, Inc.
Microbiology · 533d
Cleared May 19, 1995
QUICKVUE(R) CHLAMYDIA TEST
K946276 · LJC
Quidel Corp.
Microbiology · 147d
Cleared May 16, 1995
DRYSLIDE COAGULASE
K950706 · JTL
Difco Laboratories, Inc.
Microbiology · 90d
Cleared May 11, 1995
PS II
K943513 · LYR
Washington Biotechnology
Microbiology · 295d
Cleared May 11, 1995
LYFO(TM) DIFFERENTIAL DISK
K945487 · JSP
Microbiologics, Inc.
Microbiology · 184d
Cleared May 11, 1995
LYFO(TM) DIFFERENTIAL DISK
K945488 · JSP
Microbiologics, Inc.
Microbiology · 184d
Cleared May 11, 1995
LYFO(TM) DIFFERENTIAL DISK
K945489 · JSP
Microbiologics, Inc.
Microbiology · 184d
Cleared May 05, 1995
EBNA IGG ELISA TEST SYSTEM
K932742 · LLM
Zeus Scientific, Inc.
Microbiology · 696d
Cleared May 05, 1995
B-L RED(TM) DISCS
K950346 · JTO
Oxis Intl., Inc.
Microbiology · 98d
Cleared May 02, 1995
E TEST FOR OFLOXACIN
K946364 · JWY
Ab Biodisk
Microbiology · 134d
Cleared May 01, 1995
ELVIS HSV
K941924 · GQN
Diagnostic Hybrids, Inc.
Microbiology · 376d
Cleared Apr 27, 1995
IMX(R) TOXO IGM
K945634 · LGD
Abbott Laboratories
Microbiology · 162d
Cleared Apr 25, 1995
DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI
K950817 · JWY
Baxter Diagnostics, Inc.
Microbiology · 62d
Cleared Apr 24, 1995
LYFO(TM) DIFFERENTIAL DISK-SPS
K945880 · JTO
Microbiologics, Inc.
Microbiology · 144d
Cleared Apr 24, 1995
LYFO(TM) DIFFERENTIAL DISK-STERILE DISK
K945881 · JTO
Microbiologics, Inc.
Microbiology · 144d
Cleared Apr 24, 1995
LYFO(TM) DIFFERENTIAL DISK-BILE
K945882 · JTO
Microbiologics, Inc.
Microbiology · 144d
Cleared Apr 24, 1995
LYFO(TM) DIFFERENTIAL DISK-BILE ESCULIN
K945883 · JTO
Microbiologics, Inc.
Microbiology · 144d
Cleared Apr 20, 1995
HP-FAST
K944903 · LYR
Gi Supply
Microbiology · 198d
Cleared Apr 18, 1995
DIGENE DCR-1 LUMINOMETER
K940486 · JJQ
Digene Diagnostics, Inc.
Microbiology · 440d
Cleared Apr 14, 1995
DRIED GRAM-NEGATIVE MIC//COMBO PANELS
K935704 · LTT
Baxter Diagnostics, Inc.
Microbiology · 500d
Cleared Apr 14, 1995
PREMIER EHEC
K950167 · GNA
Meridian Diagnostics, Inc.
Microbiology · 87d