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
3145–3168 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 05, 2002
PICCOLO PHOSPHORUS TEST SYSTEM
K022312 · CEO
Abaxis, Inc.
Chemistry · 50d
Cleared Sep 03, 2002
RAICHEM LIPID CALIBRATOR
K022767 · JIX
Hemagen Diagnostics, Inc.
Chemistry · 13d
Cleared Aug 30, 2002
RANDOX LIPID CONTROL
K022591 · JJY
Randox Laboratories, Ltd.
Chemistry · 25d
Cleared Aug 30, 2002
EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE...
K021781 · CGA
Chay Medical, LLC
Chemistry · 92d
Cleared Aug 29, 2002
MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB
K022654 · JHY
Roche Diagnostics Corp.
Chemistry · 20d
Cleared Aug 27, 2002
LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS
K022491 · JJX
Cliniqa Corporation
Chemistry · 29d
Cleared Aug 23, 2002
IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25
K022538 · JIR
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 22d
Cleared Aug 23, 2002
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS...
K022072 · CIX
Precision Systems, Inc.
Chemistry · 58d
Cleared Aug 23, 2002
ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM
K021819 · NBW
Lifescan, Inc.
Chemistry · 80d
Cleared Aug 22, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438
K022707 · DIF
Bio-Rad
Chemistry · 8d
Cleared Aug 21, 2002
PTS PANELS MULTI-CHEMISTRY CONTROLS
K022401 · JJY
Polymer Technology Systems, Inc.
Chemistry · 29d
Cleared Aug 21, 2002
FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY
K021972 · CDZ
Qualigen, Inc.
Chemistry · 65d
Cleared Aug 16, 2002
PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGY
K021960 · LFR
Abbott Laboratories
Chemistry · 63d
Cleared Aug 15, 2002
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS...
K022529 · JJS
Bio-Rad
Chemistry · 15d
Cleared Aug 15, 2002
SPIFE LIPPOROTEIN-12, MODEL 3344
K022333 · JHO
Helena Laboratories
Chemistry · 28d
Cleared Aug 08, 2002
BD PRESET BLOOD COLLECTION SYRINGE, BD A-LINE BLOOD COLLECTION SYRINGE,...
K022426 · JKA
Becton, Dickinson & CO
Chemistry · 14d
Cleared Aug 05, 2002
POLY STAT HCG DIPSTICK TEST
K021386 · JHI
Alidex, Inc.
Chemistry · 95d
Cleared Aug 01, 2002
CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3
K022232 · JJX
Cliniqa Corporation
Chemistry · 22d
Cleared Jul 29, 2002
BD VACUTAINER PLUS PST II TUBE
K022130 · JKA
Becton, Dickinson & CO
Chemistry · 28d
Cleared Jul 29, 2002
RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM
K021194 · DCK
Hemagen Diagnostics, Inc.
Chemistry · 105d
Cleared Jul 25, 2002
THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050
K022108 · JIX
Thermo Dma, Inc.
Chemistry · 27d
Cleared Jul 25, 2002
J&S MEDICAL SENTRY URINE DIPSTICK CONTROL
K022085 · JJW
J & S Medical Assoc., Inc.
Chemistry · 28d
Cleared Jul 25, 2002
STAT PROFILE PHOX PLUS C ANALYZER
K021713 · CHL
Nova Biomedical Corp.
Chemistry · 63d
Cleared Jul 25, 2002
K-ASSAY LP(A) ASSAY
K021660 · DFC
Kamiya Biomedical Co.
Chemistry · 66d