Cleared Traditional

BLOOD GAS CONTROLS

K901985 · Phoenix Diagnostics, Inc. · Chemistry
Jun 1990
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K901985 is an FDA 510(k) clearance for the BLOOD GAS CONTROLS, a Controls For Blood-gases, (assayed And Unassayed) (Class I — General Controls, product code JJS), submitted by Phoenix Diagnostics, Inc. (Medfield, US). The FDA issued a Cleared decision on June 6, 1990, 35 days after receiving the submission on May 2, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K901985 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 1990
Decision Date June 06, 1990
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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