PARA-PAK— 510(k) K811722

Substantially Equivalent

Meridian Diagnostics, Inc.

FDA 510(k) clearance K811722 for PARA-PAK, Substantially Equivalent on 1981-07-15. Applicant: Meridian Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Meridian Diagnostics, Inc.
Product code: Code HYI
Device class: Class 1
Regulation: 21 CFR 864.1850
Advisory panel: Hematology
Date received: 1981-06-18
Decision date: 1981-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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