510(k) K851389— APO B RIA KIT

Substantially Equivalent

Iso-Tex Diagnostics

Clearance details

Applicant: Iso-Tex Diagnostics
Product code: Code MSJ
Advisory panel: Clinical Chemistry
Date received: 1985-04-09
Decision date: 1985-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Friendswood, TX, US

Download summary PDF View on FDA.gov ↗

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