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
2401–2424 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Feb 26, 1998
ALIMENTERICS LARA (TM) BREATH TEST SYSTEM
K973000 · MSQ
Alimenterics, Inc.
Microbiology · 198d
Cleared Feb 23, 1998
URINE SCREENING DEVICE
K972676 · JXA
Combact Diagnostic Systems , Ltd.
Microbiology · 222d
Cleared Feb 23, 1998
GREPAFLOXACIN, 5 MG, SENSI-DISC
K974578 · JTN
Becton Dickinson Microbiology Systems
Microbiology · 77d
Cleared Feb 20, 1998
DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL
K972904 · JJY
Casco Standards
Microbiology · 198d
Cleared Feb 17, 1998
CAMBRIDGE BIOTECH HUMAN LYME IGG WESTERN BLOT (90111)
K971169 · LSR
Cambridge Biotech Corp.
Microbiology · 326d
Cleared Feb 17, 1998
CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112)
K971170 · LSR
Cambridge Biotech Corp.
Microbiology · 326d
Cleared Feb 12, 1998
PASCO MIC AND MIC/ID PANELS
K974362 · JWY
Pasco Laboratories, Inc.
Microbiology · 85d
Cleared Feb 10, 1998
ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL
K974811 · JJX
Boston Biomedica, Inc.
Microbiology · 49d
Cleared Feb 05, 1998
ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL
K974809 · LSR
Boston Biomedica, Inc.
Microbiology · 44d
Cleared Feb 05, 1998
ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL
K974810 · LSR
Boston Biomedica, Inc.
Microbiology · 44d
Cleared Jan 28, 1998
BACTEC MYCO/F LYTIC CULTURE VIALS
K970333 · MDB
Becton Dickinson Microbiology Systems
Microbiology · 365d
Cleared Jan 28, 1998
RIFAMPICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971636 · JTN
Oxoid , Ltd.
Microbiology · 271d
Cleared Jan 28, 1998
DIAMEDIX IS-MEASLES IGG TEST SYSTEM
K974552 · LJB
Diamedix Corp.
Microbiology · 55d
Cleared Jan 27, 1998
VIROTROL III
K974613 · JJY
Blackhawk Biosystems, Inc.
Microbiology · 47d
Cleared Jan 22, 1998
GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90
K972576 · LQL
Accumed Intl., Inc.
Microbiology · 196d
Cleared Jan 14, 1998
ENOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K974394 · JTN
Oxoid , Ltd.
Microbiology · 55d
Cleared Jan 08, 1998
BACTEC MYCO/F LYTIC CULTURE VIALS
K970512 · MDB
Becton Dickinson Microbiology Systems
Microbiology · 331d
Cleared Jan 02, 1998
QUANTA LITE REBELLA IGG
K971304 · LFX
Inova Diagnostics, Inc.
Microbiology · 269d
Cleared Jan 02, 1998
CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800
K973457 · GMZ
Shared Systems, Inc.
Microbiology · 112d
Cleared Dec 30, 1997
WELLCOLEX E.COLI O157:H7
K971663 · GMZ
Murex Biotech , Ltd.
Microbiology · 238d
Cleared Dec 24, 1997
SYSCOS IDC - G, IDC, BSC, IDC - G
K974262 · MJX
Scantibodies Laboratory, Inc.
Microbiology · 41d
Cleared Dec 23, 1997
COMPOUND SULPHONAMIDES ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971637 · JTN
Oxoid , Ltd.
Microbiology · 235d
Cleared Dec 22, 1997
ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM
K972406 · GOD
Immunoprobe, Inc.
Microbiology · 179d
Cleared Dec 22, 1997
IMAGEN RESPIRATORY SCREEN
K973954 · GNW
Dako Diagnostics , Ltd.
Microbiology · 74d