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
1897–1920 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 17, 2008
CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2
K082107 · JJY
Cliniqa Corporation
Chemistry · 54d
Cleared Sep 16, 2008
G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8
K071132 · LCP
Tosoh Bioscience, Inc.
Chemistry · 512d
Cleared Sep 12, 2008
ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H
K081276 · CFR
Horiba Abx
Chemistry · 130d
Cleared Sep 11, 2008
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM110
K081450 · NBW
Bionime Corporation
Chemistry · 111d
Cleared Sep 10, 2008
DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR
K081789 · JIT
Siemens Healthcare Diagnostics, Inc.
Chemistry · 77d
Cleared Sep 05, 2008
PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS...
K080960 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 155d
Cleared Sep 05, 2008
OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181
K080435 · CIG
Olympus Life Science Research Europa...
Chemistry · 199d
Cleared Sep 03, 2008
ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS...
K082141 · JIT
Biokit, S.A.
Chemistry · 35d
Cleared Sep 03, 2008
OLYMPUS TOTAL BHCG TEST SYSTEN
K080094 · DHA
Olympus Life Science Research Europa...
Chemistry · 233d
Cleared Aug 29, 2008
DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE,...
K081731 · CGS
Siemens Healthcare Diagnostics
Chemistry · 71d
Cleared Aug 26, 2008
TYSONBIO LINK HEALTH MANAGEMENT SYSTEM
K081726 · NBW
Tyson Bioresearch, Inc.
Chemistry · 69d
Not Cleared Aug 26, 2008
ALLOMAP MOLECULAR EXPRESSION TESTING
DEN080007 · OJQ
Xdx
Chemistry · 11d
Cleared Aug 22, 2008
MSC LIPID CONTROL
K082067 · JJY
Maine Standards Co.
Chemistry · 31d
Cleared Aug 22, 2008
ELECSYS ANTI-TSHR CALCHECK
K080643 · JJX
Roche Diagnostics
Chemistry · 169d
Cleared Aug 21, 2008
VITROS CHEMISTRY PRODUCTS CI-DT SLIDES
K082099 · CGZ
Ortho-Clinical Diagnostics, Inc.
Chemistry · 27d
Cleared Aug 20, 2008
GENTIAN CYSTATIN C IMMUNOASSAY
K081875 · NDY
Gentian AS
Chemistry · 49d
Cleared Aug 19, 2008
AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ
K080872 · LDJ
Amedica Biotech, Inc.
Chemistry · 141d
Cleared Aug 19, 2008
TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81
K080641 · NBW
Home Diagnostics, Inc.
Chemistry · 166d
Cleared Aug 13, 2008
TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81
K080710 · NBW
Home Diagnostics, Inc.
Chemistry · 153d
Cleared Aug 08, 2008
FDTX GLUCOSE CONTROL SOLUTION
K081915 · JJX
Fujirebio Diagnostics Texas, Inc.
Chemistry · 36d
Cleared Aug 08, 2008
AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTION
K080273 · JJX
Fujirebio Diagnostics Texas, Inc.
Chemistry · 189d
Cleared Aug 08, 2008
ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS
K080167 · CEC
Siemens Healthcare Diagnostics
Chemistry · 198d
Cleared Aug 07, 2008
NEONATAL TOTAL GALACTOSE KIT
K071649 · JIA
Wallac OY
Chemistry · 416d
Cleared Aug 05, 2008
U-RIGHT TD-4247 BLOOD GLUCOSE MONITORING SYSTEM
K081957 · NBW
Taidoc Technology Corporation
Chemistry · 27d