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: Chemistry ×
13,257 results
1417–1440 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 23, 2011
TINA-QUANT HBA1C GEN.2
K110313 · LCP
Roche Diagnostics
Chemistry · 324d
Cleared Dec 20, 2011
I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE
K112430 · KHP
Abbott Pont of Care, Inc.
Chemistry · 118d
Cleared Dec 20, 2011
FORA D40 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
K101926 · NBW
Taidoc Technology Corporation
Chemistry · 529d
Cleared Dec 19, 2011
ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)
K112443 · CDD
Axis-Shield Diagnostics, Ltd.
Chemistry · 117d
Cleared Dec 15, 2011
FORA PREMIUM V10 BLOOD GLUCOSE MONITORING SYSTEM
K112275 · NBW
Taidoc Technology Corporation
Chemistry · 129d
Cleared Dec 14, 2011
HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL,...
K111753 · CHH
Hitachi Chemical Diagnostics, Inc.
Chemistry · 175d
Cleared CT Dec 09, 2011
PRESAGE ST2 ASSAY
K111452 · OYG
Critical Care Diagnostics, Inc. (Dba...
Chemistry · 198d
Cleared Dec 07, 2011
IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER...
K103544 · NBW
Agamatrix, Inc.
Chemistry · 370d
Cleared Dec 06, 2011
PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL
K111363 · JXN
Medica Corp.
Chemistry · 204d
Cleared Dec 02, 2011
MAGNESIUM ASSAY
K111915 · JGJ
Sekisui Diagnostics P.E.I., Inc.
Chemistry · 149d
Cleared Dec 02, 2011
ESENSOR WARFARIN SENSITIVITY SALIVA TEST
K110786 · NSU
GenMark Diagnostics, Inc.
Chemistry · 255d
Cleared Dec 02, 2011
ORAGENE-DX OGD-500
K110701 · OYJ
DNA Genotek, Inc.
Chemistry · 263d
Cleared Dec 01, 2011
RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI...
K112337 · JJY
Randox Laboratories, Ltd.
Chemistry · 108d
Cleared Dec 01, 2011
ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321
K111335 · CKG
Tosoh Bioscience, Inc.
Chemistry · 203d
Cleared Dec 01, 2011
PRESTIGE 24I
K103531 · CFR
Tokyo Boeki Medisys, Inc.
Chemistry · 365d
Cleared Nov 23, 2011
ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS,...
K110619 · MRG
Biokit, S.A.
Chemistry · 265d
Cleared Nov 23, 2011
ROM PLUS
K110605 · NQM
Clinical Innovations, LLC
Chemistry · 266d
Cleared Nov 22, 2011
LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS
K113139 · DIO
Lin-Zhi International, Inc.
Chemistry · 29d
Cleared Nov 22, 2011
DIMENSION CLINICAL CHEMISTRY SYSTEM
K112999 · JJE
Siemens Healthcare Diagnostics
Chemistry · 46d
Cleared Nov 22, 2011
TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE...
K112963 · NBW
Taidoc Technology Corporation
Chemistry · 48d
Cleared Nov 22, 2011
PREMIER HB9210 HBA1C ANALYZER
K112015 · LCP
Primus Corporation Dba Trinity Biotech
Chemistry · 132d
Cleared Nov 21, 2011
PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM
K110614 · DJZ
Seju Engineering Co., Ltd.
Chemistry · 263d
Cleared Nov 18, 2011
ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS...
K111960 · KHS
Elitechgroup
Chemistry · 130d
Cleared Nov 18, 2011
ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL...
K103376 · JFY
Seppim S.A.S.
Chemistry · 366d