hemoFISH Masterpanel— 510(k) K150031

Substantially Equivalent

Miacom Diagnostics GmbH

FDA 510(k) clearance K150031 for hemoFISH Masterpanel, Substantially Equivalent on 2015-10-01. Applicant: Miacom Diagnostics GmbH.

Clearance details

Applicant: Miacom Diagnostics GmbH
Product code: Code JSS
Advisory panel: Microbiology
Date received: 2015-01-08
Decision date: 2015-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dusseldorf, DE

Download summary PDF View on FDA.gov ↗

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