Cleared Traditional

SERACHEM LIQUID SPINAL FLUID CONTROL (HUMAN)

K871058 · Fisher Scientific Co., LLC · Chemistry
Apr 1987
Decision
20d
Days
Class 1
Risk

About This 510(k) Submission

K871058 is an FDA 510(k) clearance for the SERACHEM LIQUID SPINAL FLUID CONTROL (HUMAN), a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Fisher Scientific Co., LLC (Orangeburg, US). The FDA issued a Cleared decision on April 6, 1987, 20 days after receiving the submission on March 17, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K871058 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 1987
Decision Date April 06, 1987
Days to Decision 20 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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