COLOR-SLIDE RF— 510(k) K981496

Substantially Equivalent

Seradyn, Inc.

FDA 510(k) clearance K981496 for COLOR-SLIDE RF, Substantially Equivalent on 1998-06-15. Applicant: Seradyn, Inc.. Device class: 2.

Clearance details

Applicant: Seradyn, Inc.
Product code: Code DHR
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 1998-04-27
Decision date: 1998-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, 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.