IMMOCARE— 510(k) K052598

Substantially Equivalent

Care Diagnostic, Inc.

FDA 510(k) clearance K052598 for IMMOCARE, Substantially Equivalent on 2006-03-16. Applicant: Care Diagnostic, Inc.. Device class: 2.

Clearance details

Applicant: Care Diagnostic, Inc.
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 2005-09-21
Decision date: 2006-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Klamath Falls, OR, 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.