Cleared Traditional

RENALYZER PRX 90

K903034 · Swedish Trade Council USA · Chemistry

Mar 1991

Decision

245d

Days

Class 2

Risk

About This 510(k) Submission

K903034 is an FDA 510(k) clearance for the RENALYZER PRX 90, a Electrode, Ion Based, Enzymatic, Creatinine (Class II — Special Controls, product code CGL), submitted by Swedish Trade Council USA (Chicago, US). The FDA issued a Cleared decision on March 13, 1991, 245 days after receiving the submission on July 11, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number	K903034 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 11, 1990
Decision Date	March 13, 1991
Days to Decision	245 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—