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
2521–2544 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Apr 24, 1997
COPALIS TORC TOTAL ANTIBODY ASSAY
K970931 · LQN
Sienna Biotech, Inc.
Microbiology · 48d
Cleared Apr 17, 1997
GRAM SWAB
K970834 · JTO
Remel, Inc.
Microbiology · 41d
Cleared Apr 14, 1997
DISPENS-O-DISC (TM) LEVOFLOXACIN
K971120 · JTN
Difco Laboratories, Inc.
Microbiology · 18d
Cleared Apr 14, 1997
DISPENS-O-DISC SPARFLOXACIN
K971211 · JTN
Difco Laboratories, Inc.
Microbiology · 18d
Cleared Apr 08, 1997
VIDAS C. DIFFICILE TOXIN A II ASSAY
K964887 · LLH
Biomerieux Vitek, Inc.
Microbiology · 123d
Cleared Apr 08, 1997
IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER
K970227 · JJE
Dpc Cirrus
Microbiology · 81d
Cleared Apr 02, 1997
IMMULITE RUBELLA IGG
K963613 · LFX
Diagnostic Products Corp.
Microbiology · 204d
Cleared Apr 02, 1997
REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK
K970830 · JTN
Remel, Inc.
Microbiology · 26d
Cleared Apr 02, 1997
REMEL SPARFLOXACIN 5G SUSCEPTIBILTY DISK
K970831 · JTN
Remel, Inc.
Microbiology · 26d
Cleared Apr 02, 1997
INDOLE SWAB
K970833 · JTO
Remel, Inc.
Microbiology · 26d
Cleared Mar 26, 1997
BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM
K965129 · LSR
Wampole Laboratories
Microbiology · 93d
Cleared Mar 26, 1997
BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
K965131 · LSR
Wampole Laboratories
Microbiology · 93d
Cleared Mar 24, 1997
ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION)
K954301 · LFZ
Abbott Laboratories
Microbiology · 579d
Cleared Mar 24, 1997
TOXO IGG ELISA TEST
K962343 · LGD
Gull Laboratories, Inc.
Microbiology · 279d
Cleared Mar 24, 1997
CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM WITH CLINICAL TRANSPORT MEDIA...
K970597 · JSM
Medical Packaging Corp.
Microbiology · 34d
Cleared Mar 19, 1997
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE
K965190 · JWY
Accumed Intl., Inc.
Microbiology · 85d
Cleared Mar 18, 1997
RSV ANTIGEN CONTROL SLIDES
K964870 · GQG
Viral Antigens, Inc.
Microbiology · 103d
Cleared Mar 18, 1997
VZV ANTIGEN CONTROL SLIDES
K964872 · GQW
Viral Antigens, Inc.
Microbiology · 103d
Cleared Mar 18, 1997
CMV ANTIGEN CONTROL SLIDES
K964875 · GQH
Viral Antigens, Inc.
Microbiology · 103d
Cleared Mar 10, 1997
TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE...
K970100 · MJX
Simplicity Diagnostics, Inc.
Microbiology · 59d
Cleared Mar 10, 1997
EPISCREEN
K970357 · PJD
Epitope, Inc.
Microbiology · 39d
Cleared Mar 10, 1997
SPARFLOZACIN, 5 MCG, SENSI-DISC
K970385 · JTN
Becton Dickinson Microbiology Systems
Microbiology · 35d
Cleared Mar 06, 1997
LEVOFLOXACIN, 5MCG, SENSI-DISC
K970212 · JTN
Becton Dickinson Microbiology Systems
Microbiology · 44d
Cleared Mar 03, 1997
LEGIONELLA IGG/IGM ELISA TEST SYSTEM
K963318 · LHL
Armkel, LLC
Microbiology · 192d