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
2833–2856 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 30, 2004
GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS
K033055 · CGA
Diamond Diagnostics, Inc.
Chemistry · 123d
Cleared Jan 30, 2004
ESA PLASMA FREE METANEPHRINE ANALYSIS KIT
K032199 · CHQ
Esa, Inc.
Chemistry · 196d
Cleared Jan 29, 2004
HOLOTC RIA
K030655 · CDD
Axis-Shield Biochemicals, Asa
Chemistry · 332d
Cleared Jan 28, 2004
MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
K032235 · NBC
Biosite Incorporated
Chemistry · 191d
Cleared Jan 26, 2004
NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040
K033302 · CEW
Nichols Institute Diagnostics
Chemistry · 104d
Cleared Jan 22, 2004
N HIGH SENSITIVITY CRP
K033908 · NQD
Dade Behring, Inc.
Chemistry · 36d
Cleared Jan 21, 2004
IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I
K034055 · JHX
Diagnostic Products Corp.
Chemistry · 22d
Cleared Jan 16, 2004
E.P.T. PREGNANCY TEST
K033658 · LCX
Unipath , Ltd.
Chemistry · 56d
Cleared Jan 16, 2004
LIGAND PLUS CONTROL LEVEL 1-3
K033344 · JJY
Consolidated Technology
Chemistry · 88d
Cleared Jan 12, 2004
DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR,...
K033525 · DCF
Dade Behring, Inc.
Chemistry · 66d
Cleared Jan 12, 2004
BIOCENTREX CARDIAC PANEL
K033155 · MYT
Biocentrex
Chemistry · 104d
Cleared Jan 12, 2004
ROCHE ONLINE TDM LIDOCAINE
K032334 · KLR
Roche Diagnostics Corp.
Chemistry · 167d
Cleared Jan 08, 2004
PRECISION XCEED DIABETES MONITORING SYSTEM
K033845 · NBW
Abbott Laboratories
Chemistry · 28d
Cleared Jan 08, 2004
CO2 CALIBRATOR/DILUENT
K033643 · JIT
Bayer Healthcare, Diagnostics Division
Chemistry · 49d
Cleared Jan 07, 2004
ELECSYS PRECICONTROL MULTIANALYTE
K033937 · JJY
Roche Diagnostics Corp.
Chemistry · 19d
Cleared Jan 02, 2004
NOVA GLUCOSE CONTROL SOLUTIONS
K033433 · JJX
Nova Biomedical Corp.
Chemistry · 66d
Cleared Dec 24, 2003
STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI
K033487 · MMI
Dade Behring, Inc.
Chemistry · 50d
Cleared Dec 23, 2003
A1CNOW FOR HOME AND PROFESSIONAL USE
K033847 · LCP
Metrika, Inc.
Chemistry · 12d
Cleared Dec 23, 2003
TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG...
K033383 · NBC
Biosite Incorporated
Chemistry · 61d
Cleared Dec 23, 2003
DIAZYME LITHIUM ENZYMATIC ASSAY KIT
K033360 · JII
General Atomics
Chemistry · 63d
Cleared Dec 23, 2003
CLINITEST HCG PREGNANCY TEST
K032563 · JHI
Bayer Healthcare, LLC
Chemistry · 125d
Cleared Dec 23, 2003
RANDOX EVIDENCE
K030360 · DIO
Randox Laboratories, Ltd.
Chemistry · 323d
Cleared Dec 19, 2003
INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS,...
K033603 · LIG
Beckman Coulter, Inc.
Chemistry · 32d
Cleared Dec 19, 2003
BAYER SPECIAL CHEMISTRY CONTROLS
K033379 · JJY
Bayer Diagnostics Corp.
Chemistry · 58d