IRMA BLOOD ANALYSIS SYSTEM— 510(k) K981270

Name: FDA 510(k) clearance K981270
Creator: U.S. Food and Drug Administration
Published: 1998-05-01

Substantially Equivalent

Diametrics Medical, Inc.

FDA 510(k) clearance K981270 for IRMA BLOOD ANALYSIS SYSTEM, Substantially Equivalent on 1998-05-01. Applicant: Diametrics Medical, Inc.. Device class: 2.

Clearance details

Applicant: Diametrics Medical, Inc.
Product code: Code CGZ
Device class: Class 2
Regulation: 21 CFR 862.1170
Advisory panel: Clinical Chemistry
Date received: 1998-04-07
Decision date: 1998-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roseville, MN, US

Download summary PDF View on FDA.gov ↗

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