ROCKET REFERENCE PLASMA, CAT NO. 5188— 510(k) K900019

Name: FDA 510(k) clearance K900019
Creator: U.S. Food and Drug Administration
Published: 1990-01-25

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K900019 for ROCKET REFERENCE PLASMA, CAT NO. 5188, Substantially Equivalent on 1990-01-25. Applicant: Helena Laboratories. Device class: 2.

Clearance details

Applicant: Helena Laboratories
Product code: Code GGN
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 1990-01-02
Decision date: 1990-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

Download summary PDF View on FDA.gov ↗

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