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
2281–2304 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 11, 2006
DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2...
K061802 · NQD
Dade Behring, Inc.
Chemistry · 76d
Cleared Sep 11, 2006
DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR
K061795 · NBC
Dade Behring, Inc.
Chemistry · 80d
Cleared Sep 06, 2006
DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE
K062316 · JIF
Dade Behring, Inc.
Chemistry · 28d
Cleared Sep 06, 2006
DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410)
K062034 · JIX
Dade Behring, Inc.
Chemistry · 49d
Cleared Sep 06, 2006
DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL...
K061825 · DCN
Dade Behring, Inc.
Chemistry · 70d
Cleared Sep 06, 2006
URYXXON RELAX URINE ANALYZER
K061742 · JIL
Macherey-Nagel GmbH & Co. KG
Chemistry · 78d
Cleared Sep 06, 2006
HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT...
K060765 · LFR
Hemocue AB
Chemistry · 169d
Cleared Aug 30, 2006
CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)
K060578 · JKR
Scantibodies Laboratory, Inc.
Chemistry · 177d
Cleared Aug 29, 2006
DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125
K061839 · CIG
Dade Behring, Inc.
Chemistry · 61d
Cleared Aug 25, 2006
DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL - KC130)
K062122 · JIX
Dade Behring, Inc.
Chemistry · 31d
Cleared Aug 25, 2006
DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420)
K062121 · DKB
Dade Behring, Inc.
Chemistry · 31d
Cleared Aug 25, 2006
DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310)
K061923 · JIX
Dade Behring, Inc.
Chemistry · 49d
Cleared Aug 25, 2006
DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL...
K061719 · CIG
Dade Behring, Inc.
Chemistry · 67d
Cleared Aug 25, 2006
N LATEX CDT
K060677 · NAO
Dade Behring, Inc.
Chemistry · 164d
Cleared Aug 24, 2006
ABX PENTRA 400: LIPOPROTEINS
K060854 · JIT
Horiba Abx
Chemistry · 148d
Cleared Aug 21, 2006
DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
K062236 · MKW
Dade Behring, Inc.
Chemistry · 19d
Cleared Aug 21, 2006
THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS
K062128 · JHS
Dade Behring, Inc.
Chemistry · 26d
Cleared Aug 21, 2006
DIMENSION VISTA CHEMISTRY 1 CALIBRATOR, MODEL KC110
K061838 · JIX
Dade Behring, Inc.
Chemistry · 53d
Cleared Aug 16, 2006
MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
K062195 · NBW
Lifescan, Inc.
Chemistry · 15d
Cleared Aug 16, 2006
CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27
K062152 · JIT
Dade Behring, Inc.
Chemistry · 20d
Cleared Aug 16, 2006
ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA...
K060325 · CIG
Horiba Abx
Chemistry · 188d
Cleared Aug 14, 2006
DIMENSION VISTA SYSTEM TOTAL TRIIODOTHYRONINE CALIBRATOR, MODEL KC250
K061885 · JIT
Dade Behring, Inc.
Chemistry · 42d
Cleared Aug 11, 2006
DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220
K061750 · JIX
Dade Behring, Inc.
Chemistry · 51d
Cleared Aug 11, 2006
ACON URINALYSIS REAGENT STRIPS
K061559 · CDM
Acon Laboratories Co.
Chemistry · 67d