Cleared Traditional

IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE

K030035 · Diametrics Medical, Inc. · Chemistry
Jun 2003
Decision
173d
Days
Class 2
Risk

About This 510(k) Submission

K030035 is an FDA 510(k) clearance for the IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE, a Enzymatic Method, Creatinine (Class II — Special Controls, product code JFY), submitted by Diametrics Medical, Inc. (Roseville, US). The FDA issued a Cleared decision on June 25, 2003, 173 days after receiving the submission on January 3, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K030035 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 2003
Decision Date June 25, 2003
Days to Decision 173 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JFY — Enzymatic Method, Creatinine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1225

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