RA-1000 SYS-T4(THYROXINE)SERUM ANAL— 510(k) K834102

Name: FDA 510(k) clearance K834102
Creator: U.S. Food and Drug Administration
Published: 1984-03-15

Substantially Equivalent

Technicon Instruments Corp.

FDA 510(k) clearance K834102 for RA-1000 SYS-T4(THYROXINE)SERUM ANAL, Substantially Equivalent on 1984-03-15. 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: 1983-11-29
Decision date: 1984-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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