RENALYZER PRX 90— 510(k) K903034

Substantially Equivalent

Swedish Trade Council USA

FDA 510(k) clearance K903034 for RENALYZER PRX 90, Substantially Equivalent on 1991-03-13. Applicant: Swedish Trade Council USA. Device class: 2.

Clearance details

Applicant: Swedish Trade Council USA
Product code: Code CGL
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 1990-07-11
Decision date: 1991-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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