SMS, SCREEN MACHINE SYSTEM— 510(k) K852240

Name: FDA 510(k) clearance K852240
Creator: U.S. Food and Drug Administration
Published: 1985-06-11

Substantially Equivalent

Pandex Laboratories, Inc.

FDA 510(k) clearance K852240 for SMS, SCREEN MACHINE SYSTEM, Substantially Equivalent on 1985-06-11. Applicant: Pandex Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Pandex Laboratories, Inc.
Product code: Code JZT
Device class: Class 1
Regulation: 21 CFR 866.4520
Advisory panel: Immunology
Date received: 1985-05-23
Decision date: 1985-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mundelein, IL, US

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