HYCEL QUICK-LYSING HEMOGLOBIN REAGENT— 510(k) K882490

Name: FDA 510(k) clearance K882490
Creator: U.S. Food and Drug Administration
Published: 1988-07-25

Substantially Equivalent

R&D Systems, Inc.

FDA 510(k) clearance K882490 for HYCEL QUICK-LYSING HEMOGLOBIN REAGENT, Substantially Equivalent on 1988-07-25. Applicant: R&D Systems, Inc.. Device class: 1.

Clearance details

Applicant: R&D Systems, Inc.
Product code: Code GIF
Device class: Class 1
Regulation: 21 CFR 864.8200
Advisory panel: Hematology
Date received: 1988-06-16
Decision date: 1988-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, 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.