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
2233–2256 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 23, 2006
INNOVACON HCG UKTRA TEST DEVICE
K062361 · JHI
Innovacon, Inc.
Chemistry · 70d
Cleared Oct 18, 2006
AMNIOSTAT-FLM-PG
K061549 · JHG
Irvine Scientific Sales Co., Inc.
Chemistry · 135d
Cleared Oct 16, 2006
AUDIT MICROCV IMMUNOASSAY LINEARITY SET
K062668 · JJY
Aalto Scientific, Ltd.
Chemistry · 38d
Cleared Oct 16, 2006
ABL8X7 FLEX
K051968 · CGL
Radiometer Medical Aps
Chemistry · 453d
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