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
1945–1968 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Jun 30, 2008
DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERB BLOOD GLUCOSE...
K072854 · NBW
Tyson Bioresearch, Inc.
Chemistry · 269d
Cleared Jun 27, 2008
IDEAL LIFE GLUCO-MANAGER GMM 0001 BLOOD GLUCOSE MONITORING SYSTEM
K080283 · NBW
Taidoc Technology Corporation
Chemistry · 144d
Cleared Jun 27, 2008
NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265
K073537 · MQM
Siemens Medical Solutions Diagnostics
Chemistry · 193d
Cleared Jun 26, 2008
S-TEST C02
K073223 · KHS
Alfa Wassermann Diagnostic...
Chemistry · 224d