Cleared Traditional

LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509

K022525 · Bio-Rad · Immunology
Aug 2002
Decision
15d
Days
Class 1
Risk

About This 510(k) Submission

K022525 is an FDA 510(k) clearance for the LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509, a Controls For Blood-gases, (assayed And Unassayed) (Class I — General Controls, product code JJS), submitted by Bio-Rad (Irvine, US). The FDA issued a Cleared decision on August 15, 2002, 15 days after receiving the submission on July 31, 2002. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K022525 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 2002
Decision Date August 15, 2002
Days to Decision 15 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code JJS — Controls For Blood-gases, (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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