Cleared Traditional

IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE

K013938 · Diametrics Medical, Inc. · Chemistry
Jan 2002
Decision
61d
Days
Class 1
Risk

About This 510(k) Submission

K013938 is an FDA 510(k) clearance for the IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE, a Acid, Lactic, Enzymatic Method (Class I — General Controls, product code KHP), submitted by Diametrics Medical, Inc. (Roseville, US). The FDA issued a Cleared decision on January 28, 2002, 61 days after receiving the submission on November 28, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1450.

Submission Details

510(k) Number K013938 FDA.gov
FDA Decision Cleared SESE
Date Received November 28, 2001
Decision Date January 28, 2002
Days to Decision 61 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code KHP — Acid, Lactic, Enzymatic Method
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1450

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