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
2065–2088 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 09, 2007
ACCESSA CHOLESTEROL PANEL
K063852 · JKA
Home Access Health Corp.
Chemistry · 316d
Cleared Nov 06, 2007
GENTIAN CYSTATIN C IMMUNOASSAY
K071388 · NDY
Gentian AS
Chemistry · 172d
Cleared Nov 01, 2007
THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS
K070984 · LFR
Abbott Diabetes Care, Inc.
Chemistry · 209d
Cleared Oct 26, 2007
CLEVER CHEK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4209, TD-4222,...
K071493 · NBW
Taidoc Technology Corporation
Chemistry · 149d
Cleared Oct 22, 2007
QUANTRX FEMALE FERTILITY TEST
K070484 · NGA
Quantrx Biomedical Corporation
Chemistry · 244d
Cleared Oct 19, 2007
ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801
K072638 · JGQ
Roche Diagnostics Corp.
Chemistry · 31d
Cleared Oct 19, 2007
AHLSTROM GRADE 226 SPECIMEN COLLECTION PAPER
K062932 · JKA
Ahlstrom Mount Holly Springs, LLC
Chemistry · 386d
Cleared Oct 17, 2007
DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1...
K072435 · JIX
Dade Behring, Inc.
Chemistry · 48d
Cleared Oct 15, 2007
PTS PANELS CHOL+HDL PANEL TEST STRIPS
K071593 · CHH
Polymer Technology Systems, Inc.
Chemistry · 126d
Cleared Oct 15, 2007
AMNISCREEN HOME DETECTION LINER KIT
K071100 · CEN
Common Sense , Ltd.
Chemistry · 179d
Cleared Oct 12, 2007
ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP
K070146 · CDQ
Horiba Abx
Chemistry · 269d
Cleared Oct 12, 2007
ACON UTI URINARY TRACT INFECTION TEST STRIPS
K063295 · LJX
ACON Laboratories, Inc.
Chemistry · 345d
Cleared Oct 09, 2007
DCA VANTAGE, MODEL 5075
K071466 · LCP
Siemens Medical Solutions Diagnostics
Chemistry · 133d
Cleared Oct 05, 2007
ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM
K072543 · NBW
Lifescan, Inc.
Chemistry · 25d
Cleared Oct 05, 2007
ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS
K072204 · JIX
Siemens Medical Solutions Diagnostics
Chemistry · 58d
Cleared Oct 05, 2007
CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL
K071340 · KHS
Thermofisher Scientific OY
Chemistry · 144d
Cleared Oct 05, 2007
ELECSYS CORTISOL TEST SYSTEM
K070788 · NHG
Roche Diagnostics
Chemistry · 197d
Cleared Oct 03, 2007
ADVOCATE REDI-CODE BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4223E
K072039 · NBW
Taidoc Technology Corporation
Chemistry · 70d
Cleared Oct 03, 2007
AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL
K071580 · CIT
Thermofisher Scientific OY
Chemistry · 117d
Cleared Oct 01, 2007
LIAISON 25 OH VITAMIN D TOTAL
K071480 · MRG
DiaSorin, Inc.
Chemistry · 125d
Cleared Sep 27, 2007
MODIFICATION TO: JAZZ BLOOD GLUCOSE MONITORING SYSTEM
K072413 · NBW
Agamatrix
Chemistry · 30d
Cleared Sep 27, 2007
LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH
K063838 · DFC
Thermo Electron OY
Chemistry · 275d
Cleared Sep 24, 2007
VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY
K072443 · CJY
Ortho-Clinical Diagnostics, Inc.
Chemistry · 25d
Cleared Sep 20, 2007
REVOLUTION TD-4229 BLOOD GLUCOSE MONITORING SYSTEM
K072489 · NBW
Taidoc Technology Corporation
Chemistry · 16d