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
2065–2088 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 27, 2007
MODIFICATION TO: JAZZ BLOOD GLUCOSE MONITORING SYSTEM
K072413 · NBW
Agamatrix
Chemistry · 30d
Cleared Sep 27, 2007
LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH
K063838 · DFC
Thermo Electron OY
Chemistry · 275d
Cleared Sep 24, 2007
VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY
K072443 · CJY
Ortho-Clinical Diagnostics, Inc.
Chemistry · 25d
Cleared Sep 20, 2007
REVOLUTION TD-4229 BLOOD GLUCOSE MONITORING SYSTEM
K072489 · NBW
Taidoc Technology Corporation
Chemistry · 16d
Cleared Sep 20, 2007
VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1...
K072440 · CJY
Ortho-Clinical Diagnostics, Inc.
Chemistry · 21d
Cleared Sep 17, 2007
DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S)...
K071971 · LPS
Diazyme Laboratories
Chemistry · 62d
Cleared Sep 14, 2007
TOTAL PROTEIN URINE/CSF GEN.3
K071239 · JGQ
Roche Diagnostics
Chemistry · 134d
Cleared Sep 14, 2007
BACTRACK LCD ALCOHOL DETECTOR
K071067 · DJZ
Khn Solutions, LLC
Chemistry · 151d
Cleared Sep 13, 2007
ARCHITECT STAT TROPONIN-1
K070640 · MMI
Fisher Diagnostics
Chemistry · 190d
Cleared Sep 10, 2007
PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS
K071507 · NBW
Polymer Technology Systems, Inc.
Chemistry · 101d
Cleared Sep 04, 2007
ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY...
K070531 · CGZ
Thermo Fisher Scientific
Chemistry · 193d
Cleared Aug 30, 2007
EASYRA CLINICAL CHEMISTRY ANALYZER
K070057 · CGA
Medica Corp.
Chemistry · 237d
Cleared Aug 22, 2007
EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS
K071648 · JJX
Canterbury Scientific , Ltd.
Chemistry · 65d
Cleared Aug 21, 2007
OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102,...
K070708 · CEC
Olympus Life & Material Science...
Chemistry · 160d
Cleared Aug 17, 2007
STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM
K071834 · NBC
Dade Behring, Inc.
Chemistry · 45d
Cleared Aug 09, 2007
GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM
K063771 · NBW
Arkray Factory USA, Inc.
Chemistry · 231d
Cleared Aug 08, 2007
MISSION OLYMPUS AU ISE CALIBRATORS
K071039 · JIT
Diamond Diagnostics, Inc.
Chemistry · 118d
Cleared Aug 04, 2007
DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A
K071767 · NBC
Dade Behring, Inc.
Chemistry · 36d
Cleared Aug 03, 2007
ADVIA CHEMISTRY ENZYMATIC CREATININE_2
K070727 · JFY
Siemens Medical Solutions Diagnostics
Chemistry · 141d
Cleared Jul 30, 2007
ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY
K071587 · JJX
Inverness Medical Innovations, Inc.
Chemistry · 49d
Cleared Jul 30, 2007
COBAS C 111 ANALYZER
K071211 · CIT
Roche Diagnostics
Chemistry · 90d
Cleared Jul 30, 2007
ACON U120 URINE ANALYZER, MODEL U111-101
K070929 · KQO
ACON Laboratories, Inc.
Chemistry · 118d
Cleared Jul 23, 2007
ONE STEP HCG PREGNANCY TEST
K062703 · LCX
Ai DE Diagnostic Co., Ltd.
Chemistry · 315d
Cleared Jul 20, 2007
VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207,...
K071801 · JIX
Ortho-Clinical Diagnostics, Inc.
Chemistry · 18d