FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,234 results
841–864 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 26, 2015
Human Microalbumin kit for use on SPAPLUS
K143118 · DCF
The Binding Site Group , Ltd.
Chemistry · 208d
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