Cleared Traditional

IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE

K011586 · Diametrics Medical, Inc. · Chemistry
Nov 2001
Decision
177d
Days
Class 1
Risk

About This 510(k) Submission

K011586 is an FDA 510(k) clearance for the IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE, a Needle, Aspiration And Injection, Disposable (Class I — General Controls, product code GAA), submitted by Diametrics Medical, Inc. (Roseville, US). The FDA issued a Cleared decision on November 16, 2001, 177 days after receiving the submission on May 23, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K011586 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 2001
Decision Date November 16, 2001
Days to Decision 177 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code GAA — Needle, Aspiration And Injection, Disposable
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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