Cleared Traditional

IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE

K974396 · Diametrics Medical, Inc. · Hematology
Dec 1997
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K974396 is an FDA 510(k) clearance for the IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE, a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by Diametrics Medical, Inc. (Roseville, US). The FDA issued a Cleared decision on December 18, 1997, 27 days after receiving the submission on November 21, 1997. This device falls under the Hematology review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K974396 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 1997
Decision Date December 18, 1997
Days to Decision 27 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code CHL — Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1120

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