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
3025–3048 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 03, 2003
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS
K024182 · CDQ
Precision Systems, Inc.
Chemistry · 74d
Cleared Mar 03, 2003
ASCENSIA BREEZE BLOOD GLUCOSE METER
K024062 · CGA
Bayer Corp.
Chemistry · 84d
Cleared Feb 25, 2003
FIRST RESPONSE PREGNANCY TEST
K030258 · LCX
Armkel, LLC
Chemistry · 32d
Cleared Feb 24, 2003
WAKO L-TYPE GLUCOSE 2
K024281 · CFR
Wako Chemicals USA, Inc.
Chemistry · 63d
Cleared Feb 21, 2003
TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL
K030286 · NBC
Biosite Incorporated
Chemistry · 24d
Cleared Feb 21, 2003
OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)
K030045 · DIH
Olympus America, Inc.
Chemistry · 46d
Cleared Feb 21, 2003
MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT...
K024193 · MMI
Ortho-Clinical Diagnostics
Chemistry · 63d
Cleared Feb 14, 2003
ALBUMIN COBALT BINDING TEST (ACB TEST)
K023824 · NJV
Ischemia Technologies, Inc.
Chemistry · 88d
Cleared Feb 14, 2003
ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR
K023407 · CGX
Elan Diagnostics
Chemistry · 127d
Cleared Feb 12, 2003
WIENER LAB. BILIRUBINA DIRECT AA
K024116 · CIG
Wiener Laboratories Saic
Chemistry · 61d
Cleared Feb 12, 2003
WIENER LAB COLINESTERASA AA
K023992 · DIH
Wiener Laboratories Saic
Chemistry · 72d
Cleared Feb 11, 2003
BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST
K023944 · JHI
Bayer Corp.
Chemistry · 77d
Cleared Feb 07, 2003
ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS
K024194 · NBW
Lifescan, Inc.
Chemistry · 49d
Cleared Jan 31, 2003
SETPOINT CHEMISTRY CALIBRATOR
K030169 · JIX
Bayer Healthcare, LLC
Chemistry · 14d
Cleared Jan 31, 2003
CALIBRATION PACK, MODELS A9100-101S AND A9100-103S
K023792 · JIX
Thermo Orion
Chemistry · 79d
Cleared Jan 28, 2003
LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY...
K030150 · JJY
Cliniqa Corporation
Chemistry · 13d
Cleared Jan 28, 2003
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100
K023764 · JJE
Beckman Coulter, Inc.
Chemistry · 77d
Cleared Jan 27, 2003
VACUETTE TRACE ELEMENTS TUBES
K023971 · JKA
Greiner Bio-One Vacuette North America
Chemistry · 59d
Cleared Jan 24, 2003
ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3
K030102 · JJT
Bayer Healthcare, LLC
Chemistry · 14d
Cleared Jan 24, 2003
PICCOLO TOTAL CHOLESTEROL TEST SYSTEM
K023642 · CHH
Abaxis, Inc.
Chemistry · 86d
Cleared Jan 24, 2003
PICCOLO HDL TEST SYSTEM
K023640 · LBS
Abaxis, Inc.
Chemistry · 86d
Cleared Jan 24, 2003
PICCOLO TRIGLYCERIDES TEST SYSTEM
K023639 · JGY
Abaxis, Inc.
Chemistry · 86d
Cleared Jan 23, 2003
TRIAGE CARDIAC CONTROLS
K030089 · JJY
Biosite Incorporated
Chemistry · 13d
Cleared Jan 23, 2003
ASCENSIA GLUCOFACTS
K024234 · NBW
Bayer Corp.
Chemistry · 31d