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
2113–2136 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 01, 2007
SYNCHRON SYSTEMS CREATININE REAGENT
K071283 · CGX
Beckman Coulter, Inc.
Chemistry · 25d
Cleared Jun 01, 2007
SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
K071280 · CGX
Beckman Coulter, Inc.
Chemistry · 25d
Cleared Jun 01, 2007
SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
K071277 · CGX
Beckman Coulter, Inc.
Chemistry · 25d
Cleared Jun 01, 2007
IMDX SYSTEMS
K063699 · DJG
Novx Systems, Inc.
Chemistry · 170d
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