Cleared Traditional

STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III

K860906 · American Dade · Toxicology
May 1986
Decision
80d
Days
Class 1
Risk

About This 510(k) Submission

K860906 is an FDA 510(k) clearance for the STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on May 29, 1986, 80 days after receiving the submission on March 10, 1986. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K860906 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 1986
Decision Date May 29, 1986
Days to Decision 80 days
Submission Type Traditional
Review Panel Toxicology (TX)
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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