DeviceClearance

OLYMPUS HDL CHOLESTEROL REAGENT; OLYMPUS HDL CHOLESTEROL CALIBRATOR; OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA— 510(k) K014015

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K014015 for OLYMPUS HDL CHOLESTEROL REAGENT; OLYMPUS HDL CHOLESTEROL CALIBRATOR; OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA, Substantially Equivalent on 2002-02-08. Applicant: Olympus America, Inc..

Clearance details

Applicant
Olympus America, Inc.
Product code
Code LBS
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irving, TX, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.