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
865–888 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 22, 2015
Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls
K140654 · PDJ
Abbott Laboratories
Chemistry · 434d
Cleared May 22, 2015
CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM
K140068 · NBW
Polymer Technology Systems, Inc.
Chemistry · 494d
Cleared May 20, 2015
StatStrip Xpress Glucose Hospital Meter System
K150461 · PZI
Nova Biomedical Corporation
Chemistry · 86d
Cleared May 19, 2015
MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink...
K151236 · PJT
Medtronic Minimed, Inc.
Chemistry · 8d
Cleared May 19, 2015
SUPERCHECK PLUS BLOOD GLUCOSE MONITORING SYSTEM, SUPER CHECK PLUS MULTI BLOOD...
K141351 · NBW
Biotest Medical Corp.
Chemistry · 362d
Cleared May 14, 2015
Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood...
K140150 · NBW
Hmd Biomedical, Inc.
Chemistry · 477d
Cleared May 13, 2015
Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
K150356 · JXM
Healgen Scientific, LLC
Chemistry · 90d
Cleared May 13, 2015
Hematocrit and Metabolite QUALICHECK
K150226 · JJS
Radiometer Medical Aps
Chemistry · 100d
Cleared May 11, 2015
Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission...
K142543 · KQO
ACON Laboratories, Inc.
Chemistry · 243d
Cleared May 07, 2015
MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring...
K143750 · CGA
Apex BioTechnology Corp.
Chemistry · 127d
Cleared May 07, 2015
FORA GD43 Blood Glucose Monitoring System
K143467 · NBW
Taidoc Technology Corporation
Chemistry · 154d
Cleared May 06, 2015
StatStrip Glucose Hospital Meter
K150281 · PZI
Nova Biomedical Corporation
Chemistry · 90d
Cleared May 01, 2015
Elecsys Progesterone III Cal Check 5
K150955 · JJX
Roche Diagnostics
Chemistry · 22d
Cleared May 01, 2015
ADVIA Centaur TSH3-Ultra
K150403 · JLW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 72d
Cleared May 01, 2015
BGM009 BLOOD GLUCOSE MONITORING SYSTEM
K141036 · NBW
Apex BioTechnology Corp.
Chemistry · 374d
Cleared Apr 30, 2015
Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)
K150330 · JIR
ACON Laboratories, Inc.
Chemistry · 79d
Cleared Apr 30, 2015
VALIDATE Anemia Calibration Verification/ Linearity Test Kit
K142964 · JJY
Maine Standards Company, LLC
Chemistry · 198d
Cleared Apr 22, 2015
ADVIA CENTAUR TSH
K141999 · JLW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 273d
Cleared Apr 21, 2015
IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS...
K142994 · CJM
Immunodiagnostic Systems , Ltd.
Chemistry · 187d
Cleared Apr 20, 2015
I-QARE DS-W BLOOD GLUCOSE MONITORING SYSTEM
K132663 · NBW
Alliance International Co., Ltd.
Chemistry · 602d
Cleared Apr 16, 2015
i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total...
K133002 · DHA
Abbott Point of Care, Inc.
Chemistry · 569d
Cleared Apr 15, 2015
PRODIGY AUTOCODE EJECT BLOOD GLUCOSE MONITORING SYSTEM
K141914 · NBW
Ok Biotech Co., Ltd.
Chemistry · 274d
Cleared Apr 13, 2015
IMMULITE IGF Control Module, IMMULITE Gastrin Control Module
K150132 · JJX
Siemens Healthcare Diagnostics
Chemistry · 82d
Cleared Apr 10, 2015
AUTION CHECK PLUS
K142262 · JJW
Quantimetrix Corp.
Chemistry · 239d