Cleared Traditional

IRMA BLOOD ANALYSIS SYSTEM

K981270 · Diametrics Medical, Inc. · Chemistry
May 1998
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K981270 is an FDA 510(k) clearance for the IRMA BLOOD ANALYSIS SYSTEM, a Electrode, Ion-specific, Chloride (Class II — Special Controls, product code CGZ), submitted by Diametrics Medical, Inc. (Roseville, US). The FDA issued a Cleared decision on May 1, 1998, 24 days after receiving the submission on April 7, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1170.

Submission Details

510(k) Number K981270 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 1998
Decision Date May 01, 1998
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGZ — Electrode, Ion-specific, Chloride
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1170

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