REPLACEMENT REAGENTS FOR SMAC II SYSTEMS— 510(k) K852306

Name: FDA 510(k) clearance K852306
Creator: U.S. Food and Drug Administration
Published: 1985-08-02

Substantially Equivalent

Methodist Hospital of Memphis

FDA 510(k) clearance K852306 for REPLACEMENT REAGENTS FOR SMAC II SYSTEMS, Substantially Equivalent on 1985-08-02. Applicant: Methodist Hospital of Memphis. Device class: 1.

Clearance details

Applicant: Methodist Hospital of Memphis
Product code: Code JJC
Device class: Class 1
Regulation: 21 CFR 862.2150
Advisory panel: Clinical Chemistry
Date received: 1985-05-29
Decision date: 1985-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

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