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
2449–2472 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 29, 2005
CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN
K051925 · MMI
Access Bio Incorporate
Chemistry · 134d
Cleared Nov 28, 2005
ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK
K053059 · JJX
Roche Diagnostics
Chemistry · 28d
Cleared Nov 25, 2005
SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY
K051114 · JIF
Sentinel Ch. Srl
Chemistry · 207d
Cleared Nov 23, 2005
BE-CERTAIN PREGNANCY TEST
K051963 · LCX
Natureplex, LLC
Chemistry · 127d
Cleared Nov 22, 2005
URYXXON 200 URINE ANALYZER
K051034 · JIL
Macherey-Nagel GmbH & Co. KG
Chemistry · 214d
Cleared Nov 18, 2005
CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3
K052679 · JJX
Cliniqa Corporation
Chemistry · 51d
Cleared Nov 18, 2005
QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS
K051211 · NWM
Seradyn, Inc.
Chemistry · 191d
Cleared Nov 17, 2005
SENTINEL UIBC LIQUID
K051111 · JQF
Sentinel Ch. Srl
Chemistry · 199d
Cleared Nov 10, 2005
CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91
K051757 · CJY
Diagnostic Chemicals , Ltd.
Chemistry · 134d
Cleared Nov 09, 2005
LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4
K052838 · GGM
Bio-Rad
Chemistry · 33d
Cleared Nov 09, 2005
TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET
K052148 · JIT
Reference Diagnostics, Inc.
Chemistry · 93d
Cleared Nov 01, 2005
ABL80 FLEX ANALYZER
K051804 · CHL
Sendx Medical, Inc.
Chemistry · 119d
Cleared Oct 28, 2005
ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET
K052982 · JIT
Roche Diagnostics
Chemistry · 4d
Cleared Oct 26, 2005
AIMSTICK URINE REAGENT STRIPS
K051727 · CEN
Germaine Laboratories, Inc.
Chemistry · 120d
Cleared Oct 25, 2005
SENTINEL CLIN CHEM CAL
K051452 · JIX
Sentinel Ch. Srl
Chemistry · 145d
Cleared Oct 25, 2005
SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA,...
K050394 · DKZ
Medtox Diagnostics, Inc.
Chemistry · 251d
Cleared Oct 21, 2005
GEM PREMIER 3000
K052121 · CGA
Instrumentation Laboratory CO
Chemistry · 77d
Cleared Oct 18, 2005
TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013
K051888 · CEW
Scantibodies Laboratory, Inc.
Chemistry · 98d
Cleared Oct 17, 2005
ELECSYS PRECICONTROL BONE
K051543 · JJY
Roche Diagnostics Corp.
Chemistry · 129d
Cleared Oct 12, 2005
AUTOCHECK6+
K051928 · JJY
Radiometer Medical Aps
Chemistry · 86d
Cleared Oct 11, 2005
ADVIA IMS GLUCOSE ASSAY
K052163 · CFR
Bayer Healthcare, LLC
Chemistry · 63d
Cleared Oct 07, 2005
ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH
K051646 · JGS
Pointe Scientific, Inc.,
Chemistry · 108d
Cleared Oct 07, 2005
GLUCODR SUPERSENSOR SYSTEM
K050985 · NBW
All Medicus Co., Ltd.
Chemistry · 171d
Cleared Oct 06, 2005
LEADCARE II BLOOD LEAD TESTING SYSTEM
K052549 · DOF
Esa Biosciences, Inc.
Chemistry · 20d