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
2137–2160 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 25, 2007
VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT...
K071216 · JFY
Ortho-Clinical Diagnostics, Inc.
Chemistry · 23d
Cleared May 25, 2007
VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT...
K071215 · JFY
Ortho-Clinical Diagnostics, Inc.
Chemistry · 23d
Cleared May 25, 2007
ACCU-CHEK PERFORMA SYSTEM
K070585 · NBW
Roche Diagnostics Corp.
Chemistry · 85d
Cleared May 25, 2007
MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM
K070239 · NBW
Exir Pharmaceutical Co.
Chemistry · 120d
Cleared May 23, 2007
MODIFICATION TO SENTINEL CLIN CHEM CAL
K070971 · JIX
Sentinel Ch. Srl
Chemistry · 47d
Cleared May 22, 2007
AMYLASE EPS REAGENT
K070064 · JFJ
Thermo Fisher Scientific
Chemistry · 137d
Cleared May 09, 2007
ACCU-CHEK SMART PIX
K062395 · NBW
Roche Diagnostics Corp.
Chemistry · 266d
Cleared May 07, 2007
TRACKRECORD DATA MANAGEMENT SOFTWARE
K070593 · NBW
Home Diagnostics, Inc.
Chemistry · 66d
Cleared May 07, 2007
VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU
K070452 · LCP
Bio-Rad Laboratories, Inc.
Chemistry · 80d
Cleared May 07, 2007
NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY...
K070068 · CGL
Nova Biomedical Corp.
Chemistry · 119d
Cleared May 07, 2007
KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST
K062096 · LCX
Koreamedico Co. , Ltd.
Chemistry · 287d
Cleared May 04, 2007
CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1,...
K070741 · JJY
Cliniqa Corporation
Chemistry · 49d
Cleared May 04, 2007
SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT
K070626 · NQD
Beckman Coulter, Inc.
Chemistry · 59d
Cleared May 04, 2007
FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST
K070054 · LCX
Church & Dwight Co., Inc.
Chemistry · 120d
Cleared May 04, 2007
DBEST HCG PANEL TEST KIT
K061257 · JHI
Ameritek USA, Inc.
Chemistry · 365d
Cleared May 02, 2007
IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS),...
K071017 · NQD
Siemens Medical Solutions Diagnostics
Chemistry · 22d
Cleared Apr 30, 2007
CARBON DIOXIDE LIQUID STABLE REAGENT
K070251 · KHS
Pointe Scientific, Inc.,
Chemistry · 94d
Cleared Apr 30, 2007
EASY CHECK BLOOD GLUCOSE MONITORING SYSTEM
K062538 · NBW
Diacare Corp.
Chemistry · 244d
Cleared Apr 26, 2007
ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE...
K070249 · CIC
Horiba Abx
Chemistry · 90d
Cleared Apr 25, 2007
LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK,...
K070848 · JJW
Bio-Rad, Diagnostics Grp.
Chemistry · 28d
Cleared Apr 23, 2007
DIAZYME CREATININE LIQUID REAGENTS ASSAY
K062105 · JFY
Diazyme Laboratories
Chemistry · 273d
Cleared Apr 18, 2007
SMS MULTI GLUCOSE CONTROL, MODEL 2120049
K070506 · JJX
Medical Specialties Supply Co., Inc.
Chemistry · 56d
Cleared Apr 17, 2007
ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL...
K063306 · LCP
Alfa Wassermann, Inc.
Chemistry · 167d
Cleared Apr 13, 2007
MULTI-ANALYTE CHEMISTRY CALIBRATOR
K070207 · JIX
Pointe Scientific, Inc.,
Chemistry · 81d