K828574Substantially Equivalent

Novo Bmc Lab 22A Bone Mineral Content Determination in the Axial Skeleton

Name: K828574 Novo Bmc Lab 22A Bone Mineral Content Determination in the Axial Skeleton
Creator: Novo Diagnostic Systems
Published: 1983-04-04
License: https://open.fda.gov/license/

Novo Diagnostic Systems, Walker MI / Traditional, Substantially Equivalent

FDA source

K828574 is the FDA 510(k) clearance record for NOVO BMC LAB 22A BONE MINERAL CONTENT DETERMINATION IN THE AXIAL SKELETON, cleared for Novo Diagnostic Systems on 1983-04-04. FDA records list 2 510(k) clearances for Novo Diagnostic Systems, from 1983-04-04 to 1983-04-21. As of 2026-09-10, FDA records show no recalls naming K828574.

Clearance record

Decision date: 1983-04-04
Received: 1983-02-28 (35 days to decision)
Review panel: Unknown
Applicant: Novo Diagnostic Systems 4221 Richmond Rd., NW, Walker MI
Third party review: No