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
2257–2280 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 13, 2006
PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS
K062972 · JJX
Roche Diagnostics Corp.
Chemistry · 14d
Cleared Oct 13, 2006
LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT
K062808 · LPS
Catch Incorporated
Chemistry · 24d
Cleared Oct 10, 2006
DIACHEX BLOOD GLUCOSE MONITORING SYSTEM
K062829 · NBW
Tyson Bioresearch, Inc.
Chemistry · 20d
Cleared Oct 05, 2006
OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117
K061575 · CJY
Olympus America, Inc.
Chemistry · 120d
Cleared Oct 03, 2006
MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER
K062751 · JJT
Quantimetrix Corp.
Chemistry · 19d
Cleared Oct 02, 2006
ABX PENTRA AMYLASE CP
K062180 · JFJ
Horiba Abx
Chemistry · 63d
Cleared Sep 29, 2006
VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901
K062501 · JJX
Maine Standards Co.
Chemistry · 35d
Cleared Sep 29, 2006
METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY
K062242 · LAF
Lin-Zhi International, Inc.
Chemistry · 58d
Cleared Sep 29, 2006
ABX PENTRA 400 : CRP
K061138 · DCK
Horiba Abx
Chemistry · 158d
Cleared Sep 27, 2006
EPOC BLOOD ANALYSIS SYSTEM
K061597 · JGS
Epocal, Inc.
Chemistry · 111d
Cleared Sep 22, 2006
DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130
K062334 · JIX
Dade Behring, Inc.
Chemistry · 43d
Cleared Sep 22, 2006
ARCHITECT CORTISOL ASSAY
K062204 · JFT
Seradyn, Inc.
Chemistry · 52d
Cleared Sep 22, 2006
HEMOSIL HOMOCYSTEINE AND CONTROLS
K061598 · LPS
Instrumentation Laboratory CO
Chemistry · 106d
Cleared Sep 22, 2006
SELFCHECK GLUCO
K061528 · CGA
Card Guard Scientific Survival , Ltd.
Chemistry · 112d
Cleared Sep 19, 2006
EASY CHECK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM
K062235 · NBW
Taidoc Technology Corporation
Chemistry · 48d
Cleared Sep 19, 2006
EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014
K061992 · CGA
Eps Bio Technology Corp.
Chemistry · 68d
Cleared Sep 19, 2006
DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE
K061990 · DCF
Dade Behring, Inc.
Chemistry · 68d
Cleared Sep 15, 2006
PREVU POINT OF CARE SKIN STEROL TEST
K062092 · LBS
Premd, Inc.
Chemistry · 53d
Cleared Sep 15, 2006
GEM PREMIER 4000 WITH IQM, MODEL 4000
K061974 · CHL
Instrumentation Laboratory CO
Chemistry · 65d
Cleared Sep 15, 2006
ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953
K061190 · CEW
Beckman Coulter, Inc.
Chemistry · 140d
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