SMAC SYSTEM, T4 METHOD— 510(k) K800384

Name: FDA 510(k) clearance K800384
Creator: U.S. Food and Drug Administration
Published: 1980-03-19

Substantially Equivalent

Technicon Instruments Corp.

FDA 510(k) clearance K800384 for SMAC SYSTEM, T4 METHOD, Substantially Equivalent on 1980-03-19. Applicant: Technicon Instruments Corp.. Device class: 2.

Clearance details

Applicant: Technicon Instruments Corp.
Product code: Code KLI
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1980-02-22
Decision date: 1980-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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