Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Chemistry ×
13,257 results
2089–2112 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Jul 20, 2007
JAZZ BLOOD GLUCOSE MONITORING SYSTEM
K071393 · NBW
Agamatrix
Chemistry · 60d
Cleared Jul 13, 2007
ROCHE ELECSYS PTH TEST SYSTEM
K070709 · CEW
Roche Diagnostics Corp.
Chemistry · 121d
Cleared Jul 13, 2007
TRILOGY ANALYZER
K070704 · CGA
Drew Scientific, Inc.
Chemistry · 122d
Cleared Jul 13, 2007
I-CHROMA CRP TEST
K062981 · DCN
Boditech Diagnostics, Inc.
Chemistry · 287d