FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,234 results
1057–1080 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 25, 2013
LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM...
K132227 · JJY
Bio-Rad Laboratories
Chemistry · 100d
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