RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3— 510(k) K130236

Name: FDA 510(k) clearance K130236
Creator: U.S. Food and Drug Administration
Published: 2013-03-15

Substantially Equivalent

Radiometer Medical Aps

FDA 510(k) clearance K130236 for RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3, Substantially Equivalent on 2013-03-15. Applicant: Radiometer Medical Aps. Device class: 1.

Clearance details

Applicant: Radiometer Medical Aps
Product code: Code JJS
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 2013-01-30
Decision date: 2013-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bronshoj, DK

Download summary PDF View on FDA.gov ↗

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