RESOLVE-CSF— 510(k) K843122

Substantially Equivalent

Isolab, Inc.

FDA 510(k) clearance K843122 for RESOLVE-CSF, Substantially Equivalent on 1984-11-30. Applicant: Isolab, Inc.. Device class: 1.

Clearance details

Applicant: Isolab, Inc.
Product code: Code DFI
Device class: Class 1
Regulation: 21 CFR 866.5860
Advisory panel: Immunology
Date received: 1984-08-08
Decision date: 1984-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, 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.