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. Device class: 1.

Clearance details

Applicant: Miacom Diagnostics GmbH
Product code: Code JSS
Device class: Class 1
Regulation: 21 CFR 866.2660
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 ↗

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