Cleared Traditional

LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669

K022529 · Bio-Rad · Chemistry
Aug 2002
Decision
15d
Days
Class 1
Risk

About This 510(k) Submission

K022529 is an FDA 510(k) clearance for the LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669, a Controls For Blood-gases, (assayed And Unassayed) (Class I — General Controls, product code JJS), submitted by Bio-Rad (Ivrvine, 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 Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K022529 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 Chemistry (CH)
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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