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
1921–1944 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Aug 04, 2008
DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56
K081319 · JIT
Siemens Healthcare Diagnostics, Inc.
Chemistry · 84d
Cleared Jul 31, 2008
ABL 80 CO-OX SYSTEM
K080370 · CHL
Sendx Medical, Inc.
Chemistry · 170d
Cleared Jul 30, 2008
MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM
K080995 · NSU
Affymetrix, Inc.
Chemistry · 114d
Cleared Jul 29, 2008
ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP),...
K081294 · NQD
Siemens Healthcare Diagnostics, Inc.
Chemistry · 83d