Cleared Traditional

BLOOD GAS MIXTURE

K954546 · Liquid Technology Corp. · Chemistry
Dec 1995
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K954546 is an FDA 510(k) clearance for the BLOOD GAS MIXTURE, a Calibrator, Primary (Class II — Special Controls, product code JIS), submitted by Liquid Technology Corp. (Orlando, US). The FDA issued a Cleared decision on December 28, 1995, 90 days after receiving the submission on September 29, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K954546 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 1995
Decision Date December 28, 1995
Days to Decision 90 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JIS — Calibrator, Primary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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