DIRECT HDL-CHOLESTEROL REAGENT— 510(k) K990581

Substantially Equivalent

Kamiya Biomedical Co.

FDA 510(k) clearance K990581 for DIRECT HDL-CHOLESTEROL REAGENT, Substantially Equivalent on 1999-06-18. Applicant: Kamiya Biomedical Co..

Clearance details

Applicant: Kamiya Biomedical Co.
Product code: Code LBS
Advisory panel: Clinical Chemistry
Date received: 1999-02-23
Decision date: 1999-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

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