Cleared Traditional

SERALYZER III BLOOD CHEMISTRY ANALYZER

K872120 · Miles Laboratories, Inc. · Chemistry
Oct 1987
Decision
149d
Days
Class 1
Risk

About This 510(k) Submission

K872120 is an FDA 510(k) clearance for the SERALYZER III BLOOD CHEMISTRY ANALYZER, a Analyzer, Chemistry, Micro, For Clinical Use (Class I — General Controls, product code JJF), submitted by Miles Laboratories, Inc. (Elkhart, US). The FDA issued a Cleared decision on October 28, 1987, 149 days after receiving the submission on June 1, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2170.

Submission Details

510(k) Number K872120 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 1987
Decision Date October 28, 1987
Days to Decision 149 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JJF — Analyzer, Chemistry, Micro, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2170

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