EPINEPHRINE REAGENT, CAT. NO. 5367— 510(k) K910680

Name: FDA 510(k) clearance K910680
Creator: U.S. Food and Drug Administration
Published: 1991-05-20

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K910680 for EPINEPHRINE REAGENT, CAT. NO. 5367, Substantially Equivalent on 1991-05-20. Applicant: Helena Laboratories. Device class: 2.

Clearance details

Applicant: Helena Laboratories
Product code: Code GHR
Device class: Class 2
Regulation: 21 CFR 864.5700
Advisory panel: Hematology
Date received: 1991-02-15
Decision date: 1991-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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