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
1081–1104 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 24, 2013
RIGHTEST CONTROL SOLUTION
K133003 · JJX
Bionime Corporation
Chemistry · 29d
Cleared Oct 24, 2013
DA01 BLOOD GLUCOSE MONITORING SYSTEM
K132338 · NBW
Delbio Incorporation
Chemistry · 90d
Cleared Oct 23, 2013
RANDOX CSF CONTROLS LEVELS 2 AND 3
K132156 · JJY
Randox Laboratories, Ltd.
Chemistry · 104d
Cleared Oct 22, 2013
IMMULITE 2000
K133128 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 22d
Cleared Oct 22, 2013
MULTICHEM S PLUS / S PLUS (ASSAYED)
K132751 · JJY
Techno-Path Manufacturing , Ltd.
Chemistry · 49d
Cleared Oct 18, 2013
ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY
K132571 · JHY
Roche Diagnostics
Chemistry · 64d
Cleared Oct 18, 2013
QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF...
K130213 · LDJ
Lumiquick Diagnostics, Inc.
Chemistry · 262d
Cleared Oct 17, 2013
GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION
K132272 · NBW
Glooko, Inc.
Chemistry · 87d
Cleared Oct 17, 2013
FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM
K131013 · NBW
Nova Biomedical Corporation
Chemistry · 189d
Cleared Oct 16, 2013
ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP...
K132664 · CJW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 50d
Cleared Oct 15, 2013
MULTICHEM U
K131993 · JJY
Techno-Path Manufacturing , Ltd.
Chemistry · 109d
Cleared Oct 11, 2013
ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM
K131366 · LFR
Roche Diagnostics Operations, Inc.
Chemistry · 151d
Cleared Oct 10, 2013
IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL
K131662 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 125d
Cleared Oct 09, 2013
AU BICARBONATE REAGENT
K131546 · KHS
Beckman Coulter Ireland, Inc.
Chemistry · 133d
Cleared Oct 04, 2013
PATHFAST CK-MB-II CALIBRATORS
K130628 · JIT
Mitsubishi Chemical Medience Corporation
Chemistry · 210d
Cleared Oct 02, 2013
ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON...
K131975 · CFJ
Alfa Wassermann Diagnostic...
Chemistry · 96d
Cleared Oct 01, 2013
ACCESS TOTAL BHCG (5TH IS)
K130020 · DHA
Beckman Coulter, Inc.
Chemistry · 271d
Cleared Sep 26, 2013
CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR
K122370 · NBW
Bayer Healthcare
Chemistry · 416d
Cleared Sep 25, 2013
ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS...
K121790 · MMI
Beckman Coulter, Inc.
Chemistry · 464d
Cleared Sep 20, 2013
MULTICHEM IA AND IA PLUS
K132091 · JJY
Techno-Path Manufacturing , Ltd.
Chemistry · 74d
Cleared Sep 17, 2013
ABL90 FLEX ANALYZER
K131988 · CHL
Radiometer Medical Aps
Chemistry · 81d
Cleared Sep 13, 2013
ADVIA CENTAUR FT4, ADVIA CENTAUR T4
K132249 · CEC
Siemens Healthcare Diagnostics, Inc.
Chemistry · 56d
Cleared Sep 10, 2013
FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST
K123567 · LCX
Church & Dwight Co., Inc.
Chemistry · 294d
Cleared Sep 06, 2013
LIAISON XL HCG
K131037 · DHA
DiaSorin, Inc.
Chemistry · 144d