K812318Substantially Equivalent

Lipo-Sep Cholesterol Audit System

Name: K812318 Lipo-Sep Cholesterol Audit System
Creator: Isolab, Inc.
Published: 1981-09-01
License: https://open.fda.gov/license/

Isolab, Inc., Mchenry IL / Traditional, Substantially Equivalent

FDA source

K812318 is the FDA 510(k) clearance record for LIPO-SEP CHOLESTEROL AUDIT SYSTEM, cleared for Isolab, Inc. on 1981-09-01. FDA records list 44 510(k) clearances for Isolab, Inc., from 1977-10-07 to 1996-10-18. As of 2026-09-10, FDA records show no recalls naming K812318.

Clearance record

Decision date: 1981-09-01
Received: 1981-08-17 (15 days to decision)
Review panel: Unknown
Applicant: Isolab, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No