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
1633–1656 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 13, 2010
ECHO TD-3227 DUAL BLOOD PRESSURE/BLOOD GLUCOSE METER
K092875 · NBW
Taidoc Technology Corporation
Chemistry · 329d
Cleared Aug 06, 2010
ABL90 FLEX SERIES
K092686 · CEM
Radiometer Medical Aps
Chemistry · 338d
Cleared Jul 29, 2010
FORA CONTROL SOLUTION, TAIDOC CONTROL SOLUTION
K093724 · JJX
Taidoc Technology Corporation
Chemistry · 238d
Cleared Jul 28, 2010
AMPHETAMINES II ASSAY
K093664 · DKZ
Roche Diagnostics Corp.
Chemistry · 243d
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