Cleared Traditional

STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY

K862818 · American Dade · Chemistry
Aug 1986
Decision
26d
Days
Class 1
Risk

About This 510(k) Submission

K862818 is an FDA 510(k) clearance for the STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY, a Analyzer, Chemistry (photometric, Discrete), For Clinical Use (Class I — General Controls, product code JJE), submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on August 19, 1986, 26 days after receiving the submission on July 24, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2160.

Submission Details

510(k) Number K862818 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 1986
Decision Date August 19, 1986
Days to Decision 26 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JJE — Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2160

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