IL TEST IRON— 510(k) K972363

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K972363 for IL TEST IRON, Substantially Equivalent on 1997-08-15. Applicant: Instrumentation Laboratory CO. Device class: 1.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code JIY
Device class: Class 1
Regulation: 21 CFR 862.1410
Advisory panel: Clinical Chemistry
Date received: 1997-06-25
Decision date: 1997-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.