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
1489–1512 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 19, 2011
ABL90
K111897 · CHL
Radiometer Medical Aps
Chemistry · 14d
Cleared Jul 15, 2011
WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO...
K111560 · DKZ
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 42d
Cleared Jul 15, 2011
OPIATE ENZYME IMMUNOASSAY
K110298 · DJG
Lin-Zhi International, Inc.
Chemistry · 164d
Cleared Jul 15, 2011
SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT
K102643 · KQP
Astoria-Pacific, Inc.
Chemistry · 304d
Cleared Jul 15, 2011
AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND...
K093755 · NBW
Andon Medical Co., Ltd.
Chemistry · 585d
Cleared Jul 13, 2011
EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR
K101089 · DCF
Medica Corp.
Chemistry · 450d
Cleared Jul 12, 2011
EASYRA HDL REAGENT
K111036 · LBS
Medica Corporation
Chemistry · 89d
Cleared Jul 08, 2011
ELECSYS PRECICONTROL VARIA 3
K111506 · JJY
Roche Diagnostics
Chemistry · 37d
Cleared Jul 06, 2011
FORA POCT S10/TD-4258 BLOOD GLUCOSE MONITORING SYSTEM
K092688 · LFR
Taidoc Technology Corporation
Chemistry · 673d
Cleared Jul 05, 2011
VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT
K110880 · JJY
Maine Standards Company, LLC
Chemistry · 97d
Cleared Jul 01, 2011
FORA POCT MANAGMENT SYSTEM
K111029 · NBW
Taidoc Technology Corporation
Chemistry · 79d
Cleared Jun 29, 2011
THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO
K110616 · JJY
Microgenics Corp.
Chemistry · 118d
Cleared Jun 28, 2011
VITAL SERUM CONTROLS
K111063 · JJY
Vital Diagnostics (Manufacturing) Ptyltd
Chemistry · 71d
Cleared Jun 28, 2011
INDIKO
K110035 · JJE
Thermofisher Scientific OY
Chemistry · 174d
Cleared Jun 27, 2011
U-RIGHT TD-4279 BLOOD GLUCOSE MONITORING SYSTEM, FORA GD40/TD-4272 BLOOD...
K101509 · NBW
Taidoc Technology Corporation
Chemistry · 391d
Cleared Jun 23, 2011
LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL
K110239 · LDJ
Lin-Zhi International, Inc.
Chemistry · 148d
Cleared Jun 21, 2011
ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO
K110830 · CIX
Elitechgroup
Chemistry · 88d
Cleared Jun 21, 2011
EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042
K102345 · NBW
Eps Bio Technology Corp.
Chemistry · 306d
Cleared Jun 20, 2011
IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)
K110889 · LCX
Ind Diagnostics, Inc.
Chemistry · 82d
Cleared Jun 10, 2011
ABBOTT ARCHITECT LH CALIBRATORS
K111023 · JIT
Abbott Laboratories
Chemistry · 58d
Cleared Jun 10, 2011
AUTODELFIA NEONATAL IRT KIT
K110274 · JNO
Wallac Oy, A Subsidiary of...
Chemistry · 130d
Cleared Jun 10, 2011
AUDIT MICROCV IMMUNOASSAY LINEARITY SET
K103601 · JJY
Aalto Scientific, Ltd.
Chemistry · 184d
Cleared Jun 09, 2011
ELECSYS SHBG CALCHECK 5
K111349 · JJX
Roche Diagnostics
Chemistry · 27d
Cleared Jun 09, 2011
ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)
K110394 · JIX
Vital Diagnostics (Manufacturing) Ptyltd
Chemistry · 118d