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
2017–2040 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared May 07, 2001
ACON STREP A RAPID TEST STRIP
K010582 · GTY
Acon Laboratories Co.
Microbiology · 69d
Cleared Apr 26, 2001
HARDYDISK BACITRACIN, 10MCG, MODEL Z927
K011086 · JTN
Hardy Diagnostics
Microbiology · 16d
Cleared Apr 24, 2001
MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K010536 · JTN
Oxoid , Ltd.
Microbiology · 60d
Cleared Apr 24, 2001
LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K010537 · JTN
Oxoid , Ltd.
Microbiology · 60d
Cleared Apr 24, 2001
PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST
K011116 · LTT
Pasco Laboratories, Inc.
Microbiology · 62d
Cleared Apr 23, 2001
PASCO MIC AND MIC/ID PANELS
K010508 · LTT
Pasco Laboratories, Inc.
Microbiology · 61d
Cleared Apr 18, 2001
MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6
K010878 · LGC
Diagnostic Products Corp.
Microbiology · 30d
Cleared Apr 13, 2001
ADVIA CENTAUR RUBELLA IGG ASSAY
K003412 · LFX
Bayer Corp.
Microbiology · 162d
Cleared Apr 09, 2001
ETEST MEROPENEM
K010363 · JWY
Ab Biodisk
Microbiology · 61d
Cleared Mar 30, 2001
ELISA TEST, SEROLOGY
K003794 · LYR
Micro Detect, Inc.
Microbiology · 112d
Cleared Mar 15, 2001
MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST
K010523 · GTZ
Binax, Inc.
Microbiology · 21d
Cleared Mar 06, 2001
SUSCEPTIBILITY TEST PANEL
K004045 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 67d
Cleared Feb 27, 2001
SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS
K003868 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 75d
Cleared Feb 23, 2001
SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS
K003834 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 73d
Cleared Jan 25, 2001
HARDYDISK SULFISOXAZOLE
K003690 · JTN
Hardy Diagnostics
Microbiology · 56d
Cleared Jan 19, 2001
BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE...
K000884 · NDZ
Becton Dickinson Biosciences
Microbiology · 305d
Cleared Jan 19, 2001
HARDYDISK TRIMETHOPRIM 5MCG
K003554 · JTN
Hardy Diagnostics
Microbiology · 63d
Cleared Jan 17, 2001
HARDYDISK AMOXICILLIN/CLAVULANIC ACID, 20/10MCG
K003556 · JTN
Hardy Diagnostics
Microbiology · 61d
Cleared Jan 12, 2001
HARDYDISK NAFCILLIN, 1 MCG
K003536 · JTN
Hardy Diagnostics
Microbiology · 57d
Cleared Jan 12, 2001
HARDYDISK RIFAMPIN, 5MCG
K003537 · JTN
Hardy Diagnostics
Microbiology · 57d
Cleared Jan 12, 2001
HARDYDISK TICARCILLIN/CLAVULANIC ACID, 85MCG
K003686 · JTN
Hardy Diagnostics
Microbiology · 43d
Cleared Jan 09, 2001
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K003619 · LTT
Dade Microscan, Inc.
Microbiology · 48d
Cleared Dec 13, 2000
HARDY DISK, CEFPODOXINE, 10MCG
K003532 · JTN
Hardy Diagnostics
Microbiology · 27d
Cleared Nov 29, 2000
CAPTIA SYPHILIS-G ELISA TEST SYSTEM
K001525 · LIP
Trinity Biotech, Plc
Microbiology · 197d