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
1513–1536 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
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