Cleared Traditional

MULTICONSTITUENT SERUM RANGE LINEARITY #88234

K901115 · Hichem Diagnostics · Chemistry
Apr 1990
Decision
41d
Days
Class 1
Risk

About This 510(k) Submission

K901115 is an FDA 510(k) clearance for the MULTICONSTITUENT SERUM RANGE LINEARITY #88234, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Hichem Diagnostics (Brea, US). The FDA issued a Cleared decision on April 19, 1990, 41 days after receiving the submission on March 9, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K901115 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 1990
Decision Date April 19, 1990
Days to Decision 41 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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