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
1513–1536 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 27, 2011
FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL
K110641 · JJX
Fujirebio Diagnostics,Inc.
Chemistry · 84d
Cleared May 27, 2011
CLEVER CHOICE VOICE+ BLOOD GLUCOSE MONITORING SYSTEM
K102049 · NBW
Taidoc Technology Corporation
Chemistry · 310d
Cleared May 25, 2011
SYNCHRON MULTI CALIBRATOR
K110251 · JIX
Beckman Coulter, Inc.
Chemistry · 117d
Cleared May 23, 2011
EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017
K101037 · LFR
Eps Bio Technology Corp.
Chemistry · 404d
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