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
1969–1992 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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
Cleared Oct 30, 2001
HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE
K012895 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 63d
Cleared Oct 09, 2001
MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST
K991810 · NGZ
Trek Diagnostic Systems, Inc.
Microbiology · 866d
Cleared Sep 25, 2001
MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01
K010891 · LSK
Digene Corp.
Microbiology · 183d
Cleared Sep 25, 2001
HP-ONE
K012411 · LYR
Gi Supply
Microbiology · 57d