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
2665–2688 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 02, 2004
LIQUICHEK ELEVATED CRP CONTROL
K042837 · JJX
Bio-Rad
Chemistry · 19d
Cleared Nov 02, 2004
QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS
K042446 · JJW
Bio-Rad Laboratories, Inc.
Chemistry · 54d
Cleared Oct 29, 2004
TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH...
K042485 · NQD
Roche Diagnostics Corp.
Chemistry · 46d
Cleared Oct 29, 2004
DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT
K042448 · JJX
General Atomics
Chemistry · 50d
Cleared Oct 29, 2004
DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT
K042193 · LCP
Diazyme Laboratories
Chemistry · 78d
Cleared Oct 29, 2004
DIAZYME POTASSIUM ENZYMATIC ASSAY KIT
K042191 · MZV
Diazyme Laboratories
Chemistry · 78d
Cleared Oct 29, 2004
HDL-EX SEIKEN ASSAY KIT
K041090 · LBS
Denka Seiken Co., Ltd.
Chemistry · 186d
Cleared Oct 28, 2004
VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR...
K042006 · LBS
Ortho-Clinical Diagnostics, Inc.
Chemistry · 94d
Cleared Oct 28, 2004
BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR
K041478 · CGA
Becton Dickinson
Chemistry · 147d
Cleared Oct 28, 2004
BIO-CHEM ANALYZER, MODEL 100
K040750 · CEM
Clinical Analysis Corporation, Inc.
Chemistry · 219d
Cleared Oct 27, 2004
GLUCOSE TOLERANCE BEVERAGE
K042183 · MRV
Ever Scientific
Chemistry · 77d
Cleared Oct 19, 2004
FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST
K040866 · LCX
Armkel, LLC
Chemistry · 200d
Cleared Oct 15, 2004
VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 501
K041975 · JJY
Maine Standards Co.
Chemistry · 85d
Cleared Oct 15, 2004
LIQUI-HEME GLYCO A1C ASSAY
K031296 · LCP
Biodiagnostic Intl
Chemistry · 541d
Cleared Oct 08, 2004
ABL800 FLEX
K041874 · CHL
Radiometer Medical Aps
Chemistry · 88d
Cleared Oct 07, 2004
LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5
K042324 · JJY
Bio-Rad
Chemistry · 41d
Cleared Oct 07, 2004
DIAZYME SODIUM ENZYMATIC ASSAY
K042189 · MZU
Diazyme Laboratories
Chemistry · 56d
Cleared Oct 06, 2004
STAT K IN VITRO DIAGNOSTIC TEST SYSTEM
K042270 · CEM
Stat Chem, Inc.
Chemistry · 44d
Cleared Oct 04, 2004
MICROALBUMIN MULTI-CALIBRATOR SET
K042243 · JIX
Diagnostic Chemicals , Ltd.
Chemistry · 46d
Cleared Sep 30, 2004
ELECSYS FOLATE II CALSET II
K042490 · JIT
Roche Diagnostics Corp.
Chemistry · 16d
Cleared Sep 30, 2004
AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
K042425 · JLX
Wallac OY
Chemistry · 22d
Cleared Sep 30, 2004
DELFIA NEONATAL 17A-OH-PROGESTERONE KIT
K042424 · JLX
Wallac OY
Chemistry · 22d
Cleared Sep 29, 2004
ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE
K042015 · CGA
Bayer Healthcare, Diagnostics Division
Chemistry · 64d
Cleared Sep 29, 2004
ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA)
K041866 · CDZ
Axis-Shield Diagnostics, Ltd.
Chemistry · 82d