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
2257–2280 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 13, 2006
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360
K062319 · JIX
Roche Diagnostics Corp.
Chemistry · 35d
Cleared Sep 11, 2006
GLUCOSE HK NEW FORMULATION TEST SYSTEM
K062239 · CFR
Roche Diagnostics Corp.
Chemistry · 40d
Cleared Sep 11, 2006
MODIFICATION TO DIADEXUS PLAC TEST
K062234 · NOE
Diadexus, Inc.
Chemistry · 40d
Cleared Sep 11, 2006
ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151
K062058 · NBW
Bayer Healthcare
Chemistry · 53d
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