Cleared Traditional

AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

K872196 · American Dade · Chemistry
Jul 1987
Decision
53d
Days
Class 1
Risk

About This 510(k) Submission

K872196 is an FDA 510(k) clearance for the AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III, a Controls For Blood-gases, (assayed And Unassayed) (Class I — General Controls, product code JJS), submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on July 31, 1987, 53 days after receiving the submission on June 8, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K872196 FDA.gov
FDA Decision Cleared SESE
Date Received June 08, 1987
Decision Date July 31, 1987
Days to Decision 53 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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