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
1537–1560 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 20, 2011
CANNABINOIDS URINE TEST
K110182 · LDJ
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 119d
Cleared May 20, 2011
EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS
K101090 · CJE
Medica Corp.
Chemistry · 396d
Cleared May 19, 2011
ARK CARE DIABETES MANAGMENT SYSTEM
K110709 · NBW
Arkray Factory USA, Inc.
Chemistry · 66d
Cleared May 19, 2011
ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS...
K102993 · CDT
Seppim S.A.S.
Chemistry · 223d
Cleared May 19, 2011
ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C...
K100547 · LCP
Seppim S.A.S.
Chemistry · 448d
Cleared May 17, 2011
DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT
K110188 · LCP
Diazyme Laboratories
Chemistry · 113d
Cleared May 16, 2011
PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2
K100130 · MMI
Mitsubishi Chemical Medience CO
Chemistry · 482d
Cleared May 13, 2011
HEALTH CARE SYSTEM SOFTWARE
K110948 · NBW
Taidoc Technology Corporation
Chemistry · 39d
Cleared May 13, 2011
DIMENSIONS HB1C KIT, MODEL DF105A
K102510 · LCP
Siemens Healthcare Diagnostics
Chemistry · 259d
Cleared May 12, 2011
ELECSYS PROLACTIN II CALCHECK 5
K110613 · JJX
Roche Diagnostics
Chemistry · 70d
Cleared May 12, 2011
CLEARBLUE EASY PREGNANCY TEST
K110433 · LCX
SPD Development Company Limited
Chemistry · 86d
Cleared May 12, 2011
DROPPER A1C DIABETES CONTROL
K103744 · JJX
Quantimetrix Corp.
Chemistry · 140d
Cleared May 12, 2011
ROCHE ELECSYS FOLATE RBC
K103716 · CGN
Roche Diagnostics
Chemistry · 142d
Cleared May 11, 2011
POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS
K110413 · CDD
Beckman Coulter, Inc.
Chemistry · 86d
Cleared May 06, 2011
MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL
K103364 · JJY
Diamond Diagnostics, Inc.
Chemistry · 171d
Cleared May 06, 2011
URIC ACID MODEL 3P39
K102568 · KNK
Abbott Laboratories
Chemistry · 241d
Cleared May 06, 2011
ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS
K100263 · CEO
Seppim S.A.S.
Chemistry · 463d
Cleared Apr 28, 2011
IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM)
K103683 · JJX
Siemens Healthcare Diagnostics
Chemistry · 132d
Cleared Apr 28, 2011
AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIP
K102481 · NBW
Apex BioTechnology Corp.
Chemistry · 241d
Cleared Apr 27, 2011
UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800...
K103842 · CGA
Beckman Coulter, Inc.
Chemistry · 118d
Cleared Apr 27, 2011
DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET
K103557 · DCK
Diazyme Laboratories
Chemistry · 146d
Cleared Apr 22, 2011
GSP NEONATAL THYROXINE (T4)
K103484 · KLI
Wallac Oy, A Subsidiary of...
Chemistry · 147d
Cleared Apr 21, 2011
EASYRA UREA NITROGEN AND CREATININE REAGENTS
K110675 · CDQ
Medica Corp.
Chemistry · 42d
Cleared Apr 20, 2011
UCP DRUG SCREENING TEST CUPS
K110515 · DIS
Ucp Biosciences, Inc.
Chemistry · 56d