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: Chemistry ×
13,237 results
2761–2784 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 20, 2004
PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112
K040575 · CGJ
Phamatech, Inc.
Chemistry · 77d
Cleared May 20, 2004
LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL...
K033899 · NFX
Lifestream Technologies, Inc.
Chemistry · 155d
Cleared May 19, 2004
PARADIGM LINK BLOOD GLUCOSE METER
K040603 · NBW
Becton, Dickinson & CO
Chemistry · 75d
Cleared May 19, 2004
MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY
K033688 · NRH
Micro Direct, Inc.
Chemistry · 177d
Cleared May 19, 2004
FIRST SIGN DRUG OF ABUSE SCREENING TEST
K032575 · DKZ
W.H.P.M., Inc.
Chemistry · 273d
Cleared May 17, 2004
LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS
K040927 · JJX
Cliniqa Corporation
Chemistry · 38d
Cleared May 17, 2004
WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2
K040918 · JJX
Wako Chemicals USA, Inc.
Chemistry · 39d
Cleared May 17, 2004
ELECSYS TROPONIN T STAT TEST
K040733 · MMI
Roche Diagnostics Corp.
Chemistry · 56d
Cleared May 17, 2004
RAMP CK-MB ASSAY
K033747 · JHX
Response Biomedical Corp.
Chemistry · 168d
Cleared May 17, 2004
RAMP TROPONIN I ASSAY
K033745 · MMI
Response Biomedical Corp.
Chemistry · 168d
Cleared May 14, 2004
BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT...
K041071 · JKA
Becton, Dickinson & CO
Chemistry · 18d
Cleared May 14, 2004
BILIRUBIN ASSAY ON THE OMNI S ANALYZER
K040174 · MQM
Roche Diagnostics Corp.
Chemistry · 109d
Cleared May 10, 2004
AMYLASE LIQUID REAGENT, MODEL A532-200
K040920 · JFJ
Teco Diagnostics
Chemistry · 32d
Cleared May 07, 2004
NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS
K041016 · JJX
Nova Biomedical Corp.
Chemistry · 17d
Cleared Apr 30, 2004
AXSYM CYCLOSPORINE
K040761 · MKW
Abbott Laboratories, Inc.
Chemistry · 36d
Cleared Apr 29, 2004
QUICKVUE ADVANCE PH AND AMINES GLL TEST
K040008 · CEN
Quidel Corp.
Chemistry · 118d
Cleared Apr 28, 2004
MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3
K040880 · JJY
Medical Analysis Systems, Inc.
Chemistry · 23d
Cleared Apr 26, 2004
KETOCHECKS
K033114 · JIN
Neo Diagnostics, Inc.
Chemistry · 209d
Cleared Apr 23, 2004
AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR
K033860 · JIT
Wako Chemicals USA, Inc.
Chemistry · 133d
Cleared Apr 22, 2004
ACCU-CHEK GO SYSTEM
K040796 · LFR
Roche Diagnostics Corp.
Chemistry · 24d
Cleared Apr 22, 2004
NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY
K033727 · CEW
Nichols Institute Diagnostics
Chemistry · 146d
Cleared Apr 15, 2004
VARIANT II HEMOGLOBIN A1C
K040872 · LCP
Bio-Rad Laboratories, Inc.
Chemistry · 13d
Cleared Apr 15, 2004
MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM
K040814 · NBW
Abbott Laboratories
Chemistry · 16d
Cleared Apr 08, 2004
OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL CHOLESTEROL...
K040692 · JIT
Olympus America, Inc.
Chemistry · 22d