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
1921–1944 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Jul 25, 2008
FORA TD-3224 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
K081714 · CGA
Taidoc Technology Corporation
Chemistry · 37d
Cleared Jul 25, 2008
GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK
K081403 · JJX
Bionostics, Inc.
Chemistry · 67d
Cleared Jul 25, 2008
ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR
K080848 · DJZ
Q3 Innovations, LLC
Chemistry · 121d
Cleared Jul 25, 2008
LIASYS WITH MODELS LIASYS
K080468 · CFR
Ams S.R.L. Analyzer Medical System
Chemistry · 155d
Cleared Jul 23, 2008
NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS
K063841 · MRR
Liposcience
Chemistry · 575d
Cleared Jul 21, 2008
SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, WITH 21G, 23G,...
K081229 · JKA
Smiths Medical Asd, Inc.
Chemistry · 82d
Cleared Jul 21, 2008
AG-605 BLOOD GLUCOSE MONITORING SYSTEM
K073030 · NBW
Andon Health Co, Ltd.
Chemistry · 269d
Cleared Jul 21, 2008
RAMP NT-PROBNP ASSAY
K063662 · NBC
Response Biomedical Corp.
Chemistry · 591d
Cleared Jul 18, 2008
APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601,...
K080125 · LBS
Wako Chemicals USA, Inc.
Chemistry · 183d
Cleared Jul 17, 2008
APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201
K080123 · CFR
Wako Chemicals USA, Inc.
Chemistry · 182d
Cleared Jul 16, 2008
DIAZYME APOLIPOPROTEIN A-1 ASSAY
K072977 · MSJ
General Atomics
Chemistry · 268d
Cleared Jul 15, 2008
ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
K081389 · NBW
Roche Diagnostics
Chemistry · 57d
Cleared Jul 14, 2008
S40 CLINICAL ANALYZER, S TEST ALB
K072143 · CIX
Alfa Wassermann Diagnostic...
Chemistry · 347d
Cleared Jul 07, 2008
LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621
K081683 · JIT
Siemens Healthcare Diagnostics
Chemistry · 20d
Cleared Jul 03, 2008
DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS,...
K081643 · MMI
Siemens Healthcare Diagnostics
Chemistry · 21d
Cleared Jul 03, 2008
IDEAL LIFE POD (MODEL ILP 0001)
K080538 · NBW
Ideal Life, Inc.
Chemistry · 128d
Cleared Jul 02, 2008
CLEVER CHEK AND AUDIOCHEK BLOOD GLUCOSE MONITORING SYSTEMS, MODEL TD-4237
K081609 · CGA
Taidoc Technology Corporation
Chemistry · 23d
Cleared Jul 02, 2008
DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE
K081300 · JHM
Siemens Healthcare Diagnostics
Chemistry · 55d
Cleared Jun 30, 2008
VITROS CHEMISTRY PRODUCT NA+ SLIDES
K081411 · JGS
Ortho-Clinical Diagnostics, Inc.
Chemistry · 41d
Cleared Jun 30, 2008
S-TEST CREATININE (CRE)
K080073 · JFY
Alfa Wassermann, Inc.
Chemistry · 171d