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
2473–2496 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 04, 2005
HBA1C LINEARITY SET
K052010 · JJX
Cone Bioproducts
Chemistry · 71d
Cleared Oct 04, 2005
ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002
K051514 · NBW
Hypoguard USA, Inc.
Chemistry · 118d
Cleared Oct 03, 2005
IBL CORTISOL LIA TEST KIT
K052359 · CGR
Lehnus & Associates Consulting
Chemistry · 38d
Cleared Oct 03, 2005
ADVIA CHEMISTRY MICROALBUMIN CONTROLS
K052242 · JJW
Bayer Healthcare, LLC
Chemistry · 47d
Cleared Oct 03, 2005
ISE COMPENSATOR
K052193 · JIT
Roche Diagnostics
Chemistry · 53d
Cleared Oct 03, 2005
TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE)
K051969 · CHQ
Ibl GmbH
Chemistry · 75d
Cleared Sep 30, 2005
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST
K052464 · LCP
Roche Diagnostics Corp.
Chemistry · 22d
Cleared Sep 29, 2005
OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200
K052027 · CGZ
Osmetech, Inc.
Chemistry · 64d
Cleared Sep 23, 2005
DATA-TROL N NORMAL CONTROL SERUM, DATA-TROL A ABNORMAL CONTROL SERUM
K052056 · JJY
Thermo-Electron Corp.
Chemistry · 56d
Cleared Sep 22, 2005
TRIAGE BNP TEST, MODEL 98000XR
K051787 · NBC
Biosite Incorporated
Chemistry · 83d
Cleared Sep 09, 2005
WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT,...
K051810 · CEW
Scantibodies Laboratory, Inc.
Chemistry · 66d
Cleared Sep 08, 2005
STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK
K051650 · JHX
Dade Behring, Inc.
Chemistry · 79d
Cleared Sep 08, 2005
ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN...
K051297 · NEO
Roche Diagnostics Corp.
Chemistry · 113d
Cleared Sep 02, 2005
MODIFICATION TO ACCU-CHEK GO SYSTEM
K051592 · LFR
Roche Diagnostics Corp.
Chemistry · 79d
Cleared Sep 01, 2005
IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT
K050352 · JTO
Ameritek Research, LLC
Chemistry · 202d
Cleared Aug 26, 2005
C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C
K052101 · KRZ
Roche Diagnostics
Chemistry · 23d
Cleared Aug 25, 2005
ULTRA HDL
K051962 · LBS
Abbott Laboratories
Chemistry · 37d
Cleared Aug 25, 2005
SENTINEL IRON LIQUID
K051115 · JIY
Sentinel Ch. Srl
Chemistry · 115d
Cleared Aug 23, 2005
ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL,...
K051376 · CHH
Roche Diagnostics
Chemistry · 89d
Cleared Aug 22, 2005
IRON STANDARD
K052002 · JIT
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Aug 22, 2005
WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST
K051841 · JHI
W.H.P.M., Inc.
Chemistry · 46d
Cleared Aug 22, 2005
OLYMPUS CRP LATEX REAGENT, OSR6199
K051564 · NQD
Olympus America, Inc.
Chemistry · 69d
Cleared Aug 18, 2005
INVADER UGT1A1 MOLECULAR ASSAY
K051824 · NTI
Third Wave Technologies, Inc.
Chemistry · 44d
Cleared Aug 17, 2005
VANCOUVER BIOTECH HUMAN CARDIAC TROPONIN I IMMUNOASSAY TEST KIT
K050644 · MMI
Vancouver Biotech , Ltd.
Chemistry · 156d