Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Microbiology ×
7,095 results
1993–2016 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Feb 06, 2002
MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC COMBO PANELS WITH GENTAMICIN...
K020185 · LON
Dade Behring, Inc.
Microbiology · 19d
Cleared Feb 06, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMIKACIN...
K020209 · LON
Dade Behring, Inc.
Microbiology · 15d
Cleared Feb 06, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH IMIPENEM (0.25,...
K020246 · LON
Dade Behring, Inc.
Microbiology · 13d
Cleared Feb 06, 2002
MICROSCAN PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MEROPENEM (0.12-32 UG/ML)
K020249 · LON
Dade Behring, Inc.
Microbiology · 13d
Cleared Jan 24, 2002
CAPTIAM SYPHILIS-G ASSAY
K014233 · LIP
Trinity Biotech, Plc
Microbiology · 29d
Cleared Jan 17, 2002
BREATHTEK - UBIT UBT FOR H. PYLORI
K014225 · MSQ
Meretek Diagnostics, Inc.
Microbiology · 22d
Cleared Jan 10, 2002
IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM,...
K012075 · LGD
Diagnostic Products Corp.
Microbiology · 192d
Cleared Jan 10, 2002
IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2,...
K012077 · LFX
Diagnostic Products Corp.
Microbiology · 192d
Cleared Dec 27, 2001
BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY
K012183 · LGD
Bayer Diagnostics Corp.
Microbiology · 168d
Cleared Dec 21, 2001
UBIT-IR300 INFRARED SPECTROMETRY SYSTEM
K013371 · JJQ
Otsuka Pharmaceutical Co., Ltd.
Microbiology · 71d
Cleared Dec 21, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATES
K013925 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 37d
Cleared Dec 12, 2001
SAS STREPALERT
K013379 · GTY
Sa Scientific, Inc.
Microbiology · 61d
Cleared Dec 12, 2001
MICROSCAN DRIED GRAM NEGATIVE OVERNIGHT MIC/COMBO PANELS
K013423 · JWY
Dade Microscan, Inc.
Microbiology · 71d
Cleared Dec 12, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE
K013580 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 44d
Cleared Dec 10, 2001
OXOID PYLORI TEST KIT, MODEL DR0130M
K012588 · LYR
Oxoid , Ltd.
Microbiology · 122d
Cleared Nov 30, 2001
OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)
K011043 · JXA
Osmetech
Microbiology · 239d
Cleared Nov 30, 2001
INFLUENZA A/B RAPID TEST, CAT NO 2158 663
K011684 · PSZ
Roche Diagnostics Corp.
Microbiology · 184d
Cleared Nov 30, 2001
BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST
K012521 · GTZ
Binax, Inc.
Microbiology · 116d
Cleared Nov 26, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K013075 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 73d
Cleared Nov 26, 2001
BACTI-SWAB DRY
K013711 · LIO
Remel Co.
Microbiology · 19d
Cleared Nov 20, 2001
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K013368 · LTT
Trek Diagnostic Systems, Inc.
Microbiology · 40d
Cleared Nov 08, 2001
UNI-GOLD STREP A TEST KIT
K011709 · GTZ
Trinity Biotech, Plc
Microbiology · 157d
Cleared Nov 07, 2001
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP)MIC SUSCEPTIBILITY PLATES
K013195 · LTT
Trek Diagnostic Systems, Inc.
Microbiology · 43d
Cleared Nov 02, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K012921 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 63d