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
1657–1680 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 23, 2010
GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U
K100682 · JLX
Wallac OY
Chemistry · 135d
Cleared Jul 13, 2010
AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING...
K093262 · NBW
Andon Medical Co., Ltd.
Chemistry · 267d
Cleared Jul 12, 2010
IMPROVACUTER GEL & CLOT ACTIVATOR TUBE
K093910 · JKA
Guangzhou Improve Medical Instruments...
Chemistry · 202d
Cleared Jul 09, 2010
LOCI 8 CALIBRATOR, MODEL KC 646
K101460 · JIX
Siemens Healthcare Diagnostics
Chemistry · 44d
Cleared Jul 09, 2010
FORA G30A BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241
K100732 · NBW
Taidoc Technology Corporation
Chemistry · 116d
Cleared Jul 09, 2010
FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM
K100405 · CGA
Taidoc Technology Corporation
Chemistry · 143d
Cleared Jul 06, 2010
6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND...
K101195 · DJG
Lin-Zhi International, Inc.
Chemistry · 68d
Cleared Jul 01, 2010
EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031
K101457 · NBW
Eps Bio Technology Corp.
Chemistry · 36d
Cleared Jun 29, 2010
BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL 368774
K101502 · JKA
Becton, Dickinson & CO
Chemistry · 28d
Cleared Jun 28, 2010
TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277
K100322 · NBW
Taidoc Technology Corporation
Chemistry · 144d
Cleared Jun 25, 2010
IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SET
K091849 · MRG
Immunodiagnostic Systems, Inc.
Chemistry · 368d
Cleared Jun 24, 2010
DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE...
K093357 · JIT
Diamond Diagnostics, Inc.
Chemistry · 239d
Cleared Jun 18, 2010
GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2...
K093623 · CIG
Instrumentation Laboratory CO
Chemistry · 207d
Cleared Jun 18, 2010
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550
K092052 · NBW
Bionime Corporation
Chemistry · 346d
Cleared Jun 15, 2010
FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21,...
K092638 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 292d
Cleared Jun 11, 2010
ELECSYS INSULIN CALCHECK 5
K101075 · JJX
Roche Diagnostics Corp.
Chemistry · 53d
Cleared Jun 11, 2010
GSP NEONATALGALT KIT, MODEL 3303-001U
K100101 · KQP
Perkinelmer, Inc.
Chemistry · 149d
Cleared Jun 09, 2010
SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM
K100398 · NBW
Standard Diagnostics, Inc.
Chemistry · 113d
Cleared Jun 09, 2010
ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER)
K093819 · NBW
Arkray Factory USA, Inc.
Chemistry · 177d
Cleared Jun 09, 2010
EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE
K093297 · KHP
Epocal, Inc.
Chemistry · 231d
Cleared May 27, 2010
GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025
K091168 · NBW
Infopia Co, Ltd.
Chemistry · 400d
Cleared May 19, 2010
ADVIA CHEMISTRY SALICYLATE REAGENT
K093939 · DKJ
Siemens Healthcare Diagnostics
Chemistry · 148d
Cleared May 14, 2010
HDL CHOLESTEROL (HDLX) ASSAY
K100010 · LBS
Beckman Coulter, Inc.
Chemistry · 130d
Cleared May 14, 2010
FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite...
K092602 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 262d