CC-700 SEVEN PARAMETER, AUTOMATED HEMAA— 510(k) K821238

Substantially Equivalent

Dysmex

FDA 510(k) clearance K821238 for CC-700 SEVEN PARAMETER, AUTOMATED HEMAA, Substantially Equivalent on 1982-05-28. Applicant: Dysmex. Device class: 2.

Clearance details

Applicant: Dysmex
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 1982-04-28
Decision date: 1982-05-28
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.